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

Model Number	5013202400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Incontinence (1928); Muscle Weakness/Atrophy (1967); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Chills (2191); Myalgia (2238); Prolapse (2475); Hematuria (2558); Weight Changes (2607); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Decreased Appetite (4569)
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.
Event or Problem Description
As reported to coloplast, though not verified, legal representative stated continuous abdominal pain, stabbing vaginal pain, leg pain, pelvic pain, difficulty with urination and bowel movements, pain with waling, a recurrence f incontinence and dyspareunia.Exploratory surgery and revision of mesh in (b)(6) 2021.Urinary incontinence, physical deformity and loss of the ability to perform sexually.No other adverse patient effects were reported.
Event or Problem Description
Additional information received as follows: pink vaginal discharge, chills, urinary tract infection (+) mixed flora (multiple species present), hematuria, dysuria, constipation, hematochezia, nausea/vomiting.Weight loss (down to 104 lbs) due to inability to eat due to pain.Lumbar discogenic pain, myalgia, myositis, radiculopathy.Pudendal neuralgia, dyspareunia, pain at the end of urination.
Event or Problem Description
Additional information received on 2/16/2023 indicates that beginning (b)(6) 2021 the patient experienced rectocele.

• 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: 12380924
• Report Number: 2125050-2021-01204
• Device Sequence Number: 19862380
• Product Code: OTO
• UDI-Device Identifier: 05708932484084
• UDI-Public: 05708932484084
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2023

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: 5013202400
• Device Catalogue Number: 501320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/25/2022; 02/16/2023
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/05/2022; 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female