MAUDE Adverse Event Report: COLOPLAST RESTORELLE Y CONTOUR MESH

Lot Number 4801882

Device Problems Defective Device (2588); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Event Description

According to the surgeon, restorelle y contour mesh was tearing during application which should not be happening.The surgeon used restorelle l to reinforce the previous mesh.The pt had no ill effects as a result of the issue with the restorelle y contour mesh initially used.A sample of the defective product was saved and will be provided to the manufacturer's representative.Event abated after use stopped or dose reduced? yes.Diagnosis or reason for use: utero vaginal prolapse.

• Brand Name: RESTORELLE Y CONTOUR MESH
• Type of Device: RESTORELLE Y CONTOUR
• Manufacturer (Section D): COLOPLAST
• MDR Report Key: 5612271
• MDR Text Key: 43850752
• Report Number: MW5061918
• Device Sequence Number: 1
• Product Code: OTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4801882
• Other Device ID Number: 501520
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 79