MAUDE Adverse Event Report: COLOPLAST CORP RESTORELLE Y CONTOUR 24X3CM; SURGICAL MESH

Model Number 5015202400

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the physician reported having the restorelle y contour tear two years post op.

Manufacturer Narrative

This follow-up mdr is created to document the corrected 510k number.

• Brand Name: RESTORELLE Y CONTOUR 24X3CM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• MDR Report Key: 8593111
• MDR Text Key: 144485712
• Report Number: 2125050-2019-00355
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K140116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5015202400
• Device Catalogue Number: 501520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other