MAUDE Adverse Event Report: COLOPLAST CORP RESTORELLE Y SHAPED 24X4CM; SURGICAL MESH

Model Number 5014202400

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 02/22/2019

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, physician reported a colpopexy failure where the restorelle y was torn in the middle of the sacral leg.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.No components were received for evaluation.Without the benefit of analyzing the components, quality cannot confirm any observations or comment on the condition of the product.If the components become available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.Cm reviewed records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.

• Brand Name: RESTORELLE Y SHAPED 24X4CM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• MDR Report Key: 8434156
• MDR Text Key: 139250977
• Report Number: 2125050-2019-00217
• Device Sequence Number: 1
• Product Code: OTO
• 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
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Device Lot Number: 5361819
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other