COLOPLAST A/S SUPRIS RETROPUBIC KIT; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
|
Back to Search Results |
|
Catalog Number 51956 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572)
|
Event Type
Injury
|
Manufacturer Narrative
|
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
|
|
Event Description
|
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced pain, mesh erosion, urinary incontinence, urinary retention and a urinary tract infection.
|
|
Manufacturer Narrative
|
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
|
|
Event Description
|
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced pelvic pain, vaginal pain, dysuria, incontinence, mesh erosion, exposure and removal of device.
|
|
Manufacturer Narrative
|
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
|
|
Event Description
|
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced pain, mesh erosion, urinary incontinence, urinary retention, urinary tract infection, exposure, dyspareunia and removal of device.
|
|
Search Alerts/Recalls
|
|
|