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

Model Number 5014602400

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Injury (2348); Prolapse (2475); No Information (3190); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 168306149
• Report Number: 2125050-2019-00997
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 05708932484084
• UDI-Public: 05708932484084
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 5014602400
• Device Catalogue Number: 501460
• Device Lot Number: 4085005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female