MAUDE Adverse Event Report:; SURGICAL MESH

Lot Number 5698526

Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Dysuria (2684); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for august-september 2017.This mdr is to reflect the additional information to be added to the intial asr report.(patient age, lot number).The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for august-september 2017.This mdr is to reflect the additional information to be added to the intial asr report.

Event Description

Additional information reported to coloplast, though not verified, indicated extrusion and infection were reported.The sling was removed.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information received, date of birth, and updated h6 codes.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Type of Device: SURGICAL MESH
• MDR Report Key: 9713822
• MDR Text Key: 194465634
• Report Number: 2125050-2020-00094
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 5698526
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/07/2020; 07/30/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR