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

Model Number 5014202400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Bacterial Infection (1735); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

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.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced a persistent pelvic abscess in right groin which had not responded to iv antibiotics.Recurrent pelvic infection with probable pelvic mesh in involvement, although no obvious mesh infection was identified.Under general anesthesia, an explant of mid urethral sling, explant of anterior and posterior compartment mesh and diagnostic cystoscopy.Pathology report showed chronic inflammation and giant cell inflammation surrounding foreign body material.

• Brand Name: RESTORELLE Y CONTOUR
• Type of Device: 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: usjki jennifer kinneman ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11729655
• MDR Text Key: 247597481
• Report Number: 2125050-2021-00430
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K112322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Device Lot Number: 3586681
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/26/2021
• Date Device Manufactured: 03/18/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR