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

Model Number	5014302400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Incontinence (1928); Nerve Damage (1979); Pain (1994); Deformity/ Disfigurement (2360); Dyspareunia (4505); Unspecified Tissue Injury (4559)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, additional information received on 04/22/2021.Urge to urinate, hesitancy and unable to empty fully with urination, cramping with defecation, r inguinal pain, numbness and tingling in the upper anterior and lateral r thigh.Multiple pt sessions for muscle spasms/pelvic floor myalgia and poor urinary stream.(b)(6) 2018 - pre-op diagnoses of history of prior laparoscopic prolapse repair x 2, history of prior apical vaginal mesh erosion with revision, recurrent anterior apical vaginal mesh exposure and recurrent cystocele.Vaginal excision of mesh and anterior colporrhaphy and cystoscopy.Dysuria.Legal representative stated severe pain with daily activities and intercourse and required revision surgery in (b)(6) 2018.Operations to attempt to locate and remove mesh, repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various area of the pelvis, spine and the vagina and operators to remove portions of the female genitalia.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.
Additional Manufacturer Narrative
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 Y CONTOUR
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12658074
• Report Number: 2125050-2021-01511
• Device Sequence Number: 1205916
• Product Code: OTO
• UDI-Device Identifier: 05708932483896
• UDI-Public: 05708932483896
• Combination Product (Y/N): N
• PMA/510(K) Number: K112322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 5014302400
• Device Catalogue Number: 501430
• Device Lot Number: 4132746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Patient Age: 62