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U.S. Department of Health and Human Services

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

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COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH Back to Search Results
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.

 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
Type of DeviceSURGICAL 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 Key5484641
MDR Text Key39840468
Report Number2125050-2016-00022
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK103568
Number of Events Reported1
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 Received03/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number5014501022
Device Catalogue Number5014501022
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2016
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
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