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

Model Number 5013202400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Pain (1994); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced dyspareunia, pelvic pain, groin pain, vaginal pain, and recurrent urinary incontinence.Additionally erosion and exposure were noted.This device is still implanted.

Manufacturer Narrative

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

• Brand Name: RESTORELLE M
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13361024
• MDR Text Key: 285736371
• Report Number: 2125050-2022-00065
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 05708932483223
• UDI-Public: 05708932483223
• Combination Product (y/n): N
• PMA/PMN Number: K132061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/26/2022
• 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
• Patient Sex: Female