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

Model Number	5013302400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, additional information received on 4/19/2021.06/03/2021 08:52 am (gmt-5:00) added by (b)(4): additional information received on 04/19/2021.Back pain, neuropathic pain of perineum.Postoperative lower abdominal pain.Abdominal and suprapubic pain.Hydrodissection with mannitol completed.Vaginal pain.Received shock wave treatment on abdomen.Uti microscopic hematuria, cystoscopy, dyspareunia, pelvic pain.Exam under general anesthesia.Cystoscopy showed bladder base induration, erythema, and purulent exudative process at the periphery.Serial urinalysis show worsening pyuria and microscopic hematuria sometimes without positive cultures.No frank mesh erosion, but suspected that mesh may be migrating into bladder wall and causing these reactionary changes.No other adverse patient effects were reported.
Additional Manufacturer Narrative
This mdr is created as an additional follow-up to mdr record # 2125050-2019-00603, initially reported on 25-jul-2019 through e-submitter.This mdr is to reflect the additional information received.This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint, the device not being returned for evaluation and the implanted device lot number not being provided, a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: RESTORELLE XL
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12389909
• Report Number: 2125050-2021-01220
• Device Sequence Number: 4030522
• Product Code: OTO
• UDI-Device Identifier: 05708932483285
• UDI-Public: 05708932483285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5013302400
• Device Catalogue Number: 501330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1
• Patient Age: 50