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

Model Number	5014602400
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Injury (2348); Prolapse (2475); No Information (3190); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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, patient's legal representative stated plaintiff suffered serious bodily injuries, including, but not limited to, foreign body reaction, mesh protrusion, mesh erosion, pelvic pain, bowel problems, urinary problems and other injuries.
Additional Manufacturer Narrative
H6 code e2402 applied to capture "friable tissue" coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
Additional information received reported that between (b)(6) 2017 and (b)(6) 2020, the patient had experienced or was experiencing nocturia, urinary frequency, incontinence, pelvic and perineal pain.Rectocele prolapse occurred despite previous repair.Rectocele repair took place with mesh graft under general anesthesia on (b)(6) 2017.Pelvic pain on pelvic sidewall.Pelvic organ prolapse posterior compartment with a skin bridge at the perineal body.Mesh erosion, prolene suture erosion in right pelvic sidewall.First-degree cystocele and rectocele.Prolapse symptoms, right-side abdominal pain, small mesh exposure in the center of posterior vaginal wall.Excision of exposed vaginal mesh under general anesthesia.Yeast infection, mesh visible at the apex of the vagina, friable tissue and bleeding, discomfort, and early signs of mesh infection.Exposed mesh at the apex and posterior wall.Operative report (b)(6) 2020: mesh resection and cystoscopy under general anesthesia.

• Brand Name: RESTORELLE
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9386481
• Report Number: 2125050-2019-00997
• Device Sequence Number: 10880186
• Product Code: OTO
• UDI-Device Identifier: 05708932484084
• UDI-Public: 05708932484084
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5014602400
• Device Catalogue Number: 501460
• Device Lot Number: 4085005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female