MAUDE Adverse Event Report:; SURGICAL MESH

Lot Number 4878685

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Retention (2119); Blood Loss (2597); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for april-march 2019.This mdr is to reflect the additional information to be added to the intial asr report.Additional information reported to coloplast though not verified, indicated pain, spotting, mesh extrusion, urinary retention, multiple hematomas, nocturia.On (b)(6) 2016 - excision of mesh.On (b)(6) 2016 - removal of mesh.On (b)(6) 2016 - excision of mesh.

• Type of Device: SURGICAL MESH
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10343112
• MDR Text Key: 206174063
• Report Number: 2125050-2020-00581
• 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
• Report Date: 07/23/2020

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: 4878685
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1