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

Model Number	5014502400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Sexual Dysfunction (4510); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, add'l info rec'd 4/23/2021: on (b)(6) 2018 pelvic pain, uterine prolapse.Examination under anesthesia, total hysterectomy with bilateral salpingo-oophorectomy, extensive lysis of adhesions.Intraoperative findings: palpable supris with good support, extensive bladder adhesions from prior supris/ restorelle/acell surgery, extensive pelvic adhesions, total uterine prolapse with cervix and portion of lower uterine segment extending past introitus.No other adverse patient effects were reported.
Additional Manufacturer Narrative
This mdr is created as an additional follow-up to mdr record #2125050-2020-00267, initially reported on 23-mar-2020 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.Device not returned.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12419025
• Report Number: 2125050-2021-01259
• Device Sequence Number: 3593700
• Product Code: FTL
• UDI-Device Identifier: 05708932484022
• UDI-Public: 05708932484022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

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: 5014502400
• Device Catalogue Number: 501450
• Device Lot Number: 5094464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1
• Patient Age: 53 YR