MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y; SURGICAL MESH

Model Number 5014202400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, this patient had a sling implanted after a total laparoscopic hysterectomy and bilateral salpingectomy.Subsequently, the patient developed egpa following mesh implantation and was scheduled for mesh removal.This was cancelled due to vaginal burning.No plans to remove mesh right now due to high-dose steroids, currently with white-yellow discharge.

• Brand Name: RESTORELLE Y
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12373801
• MDR Text Key: 268345746
• Report Number: 2125050-2021-01203
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• Combination Product (y/n): N
• PMA/PMN Number: K112322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR