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

Device Problem Stretched (1601)

Patient Problems Pain (1994); Scarring (2061); Discomfort (2330); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the patient had surgery for bladder prolapse with restorelle y.After less than three months, the mesh had stretched.It was reported that the patient's new surgeon knew how to remove it and replace it and also repair the scarring.The patient was experiencing severe pain so the mesh was explanted.A non-coloplast mesh was implanted.The surgery and recovery were painful.The patient is no longer experiencing pain.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information received.

Event Description

Additional information indicated a few months after implant the patient's prolapse was back.The patient reported discomfort and pain.

• Brand Name: RESTORELLE Y
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9856189
• MDR Text Key: 184167190
• Report Number: 2125050-2020-00256
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR