MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE L RECT 24X8CM; SURGICAL MESH

Model Number 5014402400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Pain (1994)

Event Date 11/26/2014

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.This mdr has been created to document the asr / product code oto / exemption # (b)(4).Total number of events: 18.Restorelle: 17 initial, 1 follow-up.[oto october- november 2018].

Event Description

As reported to coloplast though not verified, patient's legal representative stated severe pain with daily activities and intercourse, vaginal pain, bowel problems as well as mesh erosion.

• Brand Name: RESTORELLE L RECT 24X8CM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8181480
• MDR Text Key: 130914176
• Report Number: 2125050-2018-00880
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K122440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014402400
• Device Catalogue Number: 501440
• Device Lot Number: 4002495
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other