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

Model Number 5014501022

Device Problem Positioning Problem (3009)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Mesh exposure in right fornix of vagina. Failure of healing along suture line. 0. 5cm piece of mesh trimmed.

Manufacturer Narrative

After receiving this complaint, we searched for other complaint and we didn't find another complaint on this lot n° for the same issue. Checking the documentation process revealed that the finished product (b)(4) (lot n°4396949) was made by our (b)(4) subcontractor on jan 2015. Checking the quality databases revealed no recorded anomaly in connection with the described incident. We received an opened pouch printed aa6114 lot n°4396949 and 3 sealed folysil catheter with a orange valve printed "15ml-4396949". The catheter have distal tips with or without silicone burrs, however, the product remains functional. Based on the above, this complaint is confirmed as a product defect. No corrective action as the product remains functional.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5484641
• MDR Text Key: 39840468
• Report Number: 2125050-2016-00022
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 5014501022
• Device Catalogue Number: 5014501022
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/23/2016
• 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?

Type of Device Usage

Patient Treatment Data

Date Received: 03/07/2016 Patient Sequence Number: 1