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	Bacterial Infection (1735); Pain (1994); Abnormal Vaginal Discharge (2123); Genital Bleeding (4507)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is created as an additional follow-up.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.
Event or Problem Description
As reported to coloplast, though not verified, additional information received on 04/28/2021.(b)(6) 2012: restorelle xl used for sacrocolpopexy with prolene and ethibond sutures, lysis of adhesions.Intraoperative findings: rectovaginal space scarring presumed from prior episiotomy/surgical procedure, denuded posterior vaginal epithelium (trimmed), mainly omental adhesions to midline right anterior abdominal wall.Severe vaginal pain/irritation, vaginal bleeding, golf ball size vaginal lump with yellow discharge/odor x 3 months.Posterior vaginal vault restorelle xl exposure at 6:00, flesh colored/soft vaginal lump with yellow odorous discharge adjacent to restorelle xl/coloplast exposure that is tender to palpation, small erythematous lesion at 11:00 above cervix that is non-tender to palpation, acute bacterial vaginitis.

• Brand Name: RESTORELLE XL
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12389486
• Report Number: 2125050-2021-01210
• Device Sequence Number: 11769851
• 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: 2012
• 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
• Device Lot Number: 3193614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 08/30/2021
• Patient Sequence Number: 1