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This device is manufactured by DAVOL SUB CR BARD.
The following problems were reported about this device:
Year | Description | Events/year | Type |
---|---|---|---|
2024 | Pain | 2 | Patient |
2024 | Insufficient Information | 21 | Patient |
2024 | Patient Device Interaction Problem | 19 | Device |
2024 | Defective Device | 19 | Device |
2023 | Pain | 7 | Patient |
2023 | Insufficient Information | 32 | Patient |
2023 | Patient Device Interaction Problem | 31 | Device |
2023 | Defective Device | 31 | Device |
2022 | Patient Device Interaction Problem | 21 | Device |
2022 | Defective Device | 21 | Device |
2019 | Use of Device Problem | 1 | Device |
2019 | Material Split, Cut or Torn | 1 | Device |
2019 | Insufficient Information | 175 | Device |
2019 | Device Damaged by Another Device | 1 | Device |
2019 | Defective Device | 178 | Device |
2018 | Pain | 1 | Patient |
2018 | Insufficient Information | 1 | Patient |
2018 | Patient Device Interaction Problem | 1 | Device |
2018 | Insufficient Information | 92 | Device |
2018 | Defective Device | 90 | Device |
2017 | Hernia | 1 | Patient |
2017 | Adhesion(s) | 1 | Patient |
2017 | Abdominal Pain | 2 | Patient |
2017 | Patient Device Interaction Problem | 2 | Device |
2017 | Migration or Expulsion of Device | 2 | Device |
2017 | Material Deformation | 1 | Device |
2017 | Insufficient Information | 20 | Device |
2017 | Detachment of Device or Device Component | 2 | Device |
2017 | Defective Device | 14 | Device |
2016 | Urinary Tract Infection | 1 | Patient |
2016 | Urinary Incontinence | 1 | Patient |
2016 | Scar Tissue | 1 | Patient |
2016 | Pain | 2 | Patient |
2016 | Inflammation | 1 | Patient |
2016 | Impaired Healing | 1 | Patient |
2016 | Hernia | 1 | Patient |
2016 | Fistula | 1 | Patient |
2016 | Erosion | 1 | Patient |
2016 | Adhesion(s) | 1 | Patient |
2016 | Torn Material | 1 | Device |
2016 | Patient Device Interaction Problem | 3 | Device |
2016 | Migration | 1 | Device |
2016 | Material Protrusion/Extrusion | 1 | Device |
2016 | Insufficient Information | 8 | Device |
2016 | Extrusion | 1 | Device |
2016 | Device Appears to Trigger Rejection | 1 | Device |
2016 | Detachment of Device or Device Component | 1 | Device |
2016 | Defective Device | 9 | Device |
2016 | Break | 1 | Device |
2015 | Sepsis | 1 | Patient |
2015 | Impaired Healing | 1 | Patient |
2015 | Hernia | 1 | Patient |
2015 | Fibrosis | 1 | Patient |
2015 | Drug Resistant Bacterial Infection | 1 | Patient |
2015 | Adhesion(s) | 4 | Patient |
2015 | Abscess | 1 | Patient |
2015 | Abdominal Pain | 1 | Patient |
2015 | Patient Device Interaction Problem | 5 | Device |
2015 | Material Deformation | 2 | Device |
2015 | Insufficient Information | 16 | Device |
2015 | Inadequate User Interface | 1 | Device |
2015 | Device Appears to Trigger Rejection | 1 | Device |
2015 | Defective Device | 19 | Device |
2015 | Break | 2 | Device |
2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
2014 | Unspecified Infection | 1 | Patient |
2014 | Seroma | 1 | Patient |
2014 | Hernia | 1 | Patient |
2014 | Fistula | 1 | Patient |
2014 | Erythema | 1 | Patient |
2014 | Adhesion(s) | 1 | Patient |
2014 | Abscess | 1 | Patient |
2014 | Abdominal Pain | 1 | Patient |
2014 | Patient Device Interaction Problem | 4 | Device |
2014 | Insufficient Information | 15 | Device |
2014 | Device Dislodged or Dislocated | 1 | Device |
2014 | Defective Device | 17 | Device |
2014 | Break | 2 | Device |
2013 | Insufficient Information | 9 | Device |
2013 | Defective Device | 9 | Device |
2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
2012 | Pain | 1 | Patient |
2012 | Insufficient Information | 1 | Patient |
2012 | Patient Device Interaction Problem | 1 | Device |
2012 | Material Deformation | 1 | Device |
2012 | Insufficient Information | 8 | Device |
2012 | Detachment of Device or Device Component | 1 | Device |
2012 | Defective Device | 10 | Device |
2011 | Purulent Discharge | 2 | Patient |
2011 | Pain | 1 | Patient |
2011 | Fibrosis | 1 | Patient |
2011 | Drug Resistant Bacterial Infection | 1 | Patient |
2011 | Bacterial Infection | 1 | Patient |
2011 | Adhesion(s) | 1 | Patient |
2011 | Patient Device Interaction Problem | 3 | Device |
2011 | Insufficient Information | 14 | Device |
2011 | Defective Device | 14 | Device |
2010 | Insufficient Information | 3 | Device |
2010 | Defective Device | 3 | Device |
2009 | Pain | 1 | Patient |
2009 | Insufficient Information | 1 | Patient |
2009 | Patient Device Interaction Problem | 1 | Device |
2009 | Insufficient Information | 5 | Device |
2009 | Defective Device | 6 | Device |
2008 | Seroma | 1 | Patient |
2008 | Pain | 1 | Patient |
2008 | Insufficient Information | 1 | Patient |
2008 | Inflammation | 1 | Patient |
2008 | Hernia | 1 | Patient |
2008 | Hematoma | 1 | Patient |
2008 | Adhesion(s) | 1 | Patient |
2008 | Abdominal Pain | 1 | Patient |
2008 | Patient Device Interaction Problem | 2 | Device |
2008 | Insufficient Information | 4 | Device |
2008 | Defective Device | 5 | Device |
2007 | Insufficient Information | 3 | Device |
2007 | Human-Device Interface Problem | 1 | Device |
2007 | Defective Device | 3 | Device |
2006 | Insufficient Information | 1 | Device |
2006 | Defective Device | 1 | Device |
2005 | Material Deformation | 1 | Device |
2005 | Folded | 1 | Device |
2005 | Defective Device | 1 | Device |
2004 | Insufficient Information | 1 | Device |
2004 | Defective Device | 1 | Device |
2002 | Insufficient Information | 1 | Device |
2001 | Insufficient Information | 1 | Device |
2001 | Defective Device | 1 | Device |