MAUDE Adverse Event Report:; SURGICAL MESH

Lot Number 1900481

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Discharge (2225); Stenosis (2263); Deformity/ Disfigurement (2360); 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 (b)(6) 2016.This mdr is to reflect the additional information to be added to the "intial" asr report (event information, lot number, and h6 patient codes).(b)(4).

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for (b)(6) 2016.This mdr is to reflect the additional information to be added to the "intial" asr report.According to the available information the patient's legal representative stated chronic pseudomembranous urethra trigonitis secondary to distal urethral stenosis.Further information received from legal representative stated severe pain with daily activities and intercourse.Patient has suffered severe emotional pain and injury and has suffered, and will suffer, apprehension of increased risk for injuries, infections, pain, mental anguish, discharge and multiple corrective surgeries as a result.Also urinary incontinence, physical deformity and the loss of the ability to perform sexually.

• Type of Device: SURGICAL MESH
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 9849903
• MDR Text Key: 188367370
• Report Number: 2125050-2020-00211
• 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: 03/05/2020

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: 1900481
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2020
• Type of Device Usage: N
• Patient Sequence Number: 1