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

Model Number	5013202400
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erythema (1840); Inflammation (1932); Itching Sensation (1943); Pain (1994); Skin Erosion (2075); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Dizziness (2194); Malaise (2359); Prolapse (2475); Fibrosis (3167); Constipation (3274); Genital Bleeding (4507); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
As reported to coloplast, though not verified the patient with this device experienced chronic pain and a fibrotic reaction.It was reported that they also experienced erosion, recurrent incontinence, constipation, and recurrence of pelvic organ prolapse.The patient had many revision surgeries and had the mesh fully removed.
Event or Problem Description
Additional information received further reported that the patient underwent partial excision of unknown transobturator tape (tot) and implant of another manufacturer¿s implant.Restorelle m was used for sacrocolpopexy with ethibond sutures.The patient experienced intermittent pain, itching, and burning around episiotomy, vulvar/vaginal swelling, pelvic pressure, and her husband began feeling the mesh during intercourse.On exam, restorelle m and ethibond suture exposure (one centimeter) was identified at the vaginal apex.The patient underwent partial excision of the restorelle m mesh.The patient also experienced vaginal bleeding, discharge, cramping, and bacterial vaginosis symptoms after recent intercourse.Exposure of the restorelle m recurred (two centimeters in diameter) and the patient underwent partial excision of the mesh.At that time, the patient also underwent lysis of bowel adhesions, and vaginal apex re-attachment to the sacral portion of the restorelle m.The patient also experienced vaginal bleeding with odor, dizziness, fatigue, and was generally not feeling well; on exam, recurrent restorelle m and ethibond suture exposure were identified.The restorelle m was trimmed in the office.The patient underwent closure of the vaginal cuff incision dehiscence.During a vaginoscopy, the restorelle m and sutures were found eroded through the vagina.The restorelle m was completely excised; the patient also underwent partial vaginectomy, massive adhesiolysis, application of advaseal, cystoscopy, and rectosigmoidscopy.Intraoperative findings: erosion, significant phlegman mass/abscess surrounding the mesh, a small portion of the plegmon mass was left attached to a portion of the small bowel due to the risk of bowel perforation if it were to be removed.Subsequently, on exam, there was a dime-size area of redness at the top of the vagina.
Additional Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: RESTORELLE M
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13237147
• Report Number: 2125050-2022-00029
• Device Sequence Number: 4307529
• Product Code: OTO
• UDI-Device Identifier: 05708932483223
• UDI-Public: 05708932483223
• Combination Product (Y/N): N
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/29/2020
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Device Lot Number: 5550425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 04/10/2022; 09/23/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 04/20/2022; 10/05/2022
• Date Device Manufactured: 03/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female