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

Model Number 5014201400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Deformity/ Disfigurement (2360); Prolapse (2475); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, patient's legal representative stated severe pain with daily activities and intercourse and ultimately required a revision surgery.Operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various area of the pelvis, spine and the vagina and operators to remove portions of the female genitalia.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.

Event Description

Additional information received further reported that in (b)(6) 2016, the patient was experiencing or had experienced recurrent apical vaginal prolapse and adhesions.

Manufacturer Narrative

D1: brand name corrected from restorelle - unknown to restorelle y.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: RESTORELLE Y
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1-3; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10098809
• MDR Text Key: 193437486
• Report Number: 2125050-2020-00404
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 5014201400
• Device Catalogue Number: 501420
• Device Lot Number: 4002493
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 09/06/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female