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

Model Number 5014201022

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.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 mesh was trimmed to about half (lengthwise).When the peritoneum closed, the mesh was seen fraying.Another mesh was used to handle the implant, the old implant broke off.Two days earlier it was noticed that after tacking in the promontorium, a small hole in the mesh appeared next to a tack.

Event Description

Additional information received indicated that the mesh was partly attached on the side of the vagina and another mesh [non-coloplast] was placed over the prometorium.The patient now has six tackers instead of three and a double mesh.The tackers were placed in the "normal places with a lot of extra material present above tacks." the y-mesh was cut in half to a width that the medical staff is used to with the non-coloplast mesh.After cutting the mesh the medical staff noted the center of the mesh was a bit "frayed", but the procedure continued until during the procedure they noted the fiber was broken further.

Manufacturer Narrative

This follow-up mdr is created to document the corrected event date, additional event information, and conclusion of the investigation.A restorelle y-mesh was received for evaluation.Examination of the returned mesh revealed the length edges to not be uniformly cut on a couple of the strips of mesh.This is indicative of the mesh not being cut in a straight line.The mesh was intact with no blood residue noted.A review of the device history by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed there are no other complaints of this lot number.A review of the nonconformances and capas revealed no trends for this lot.The contract manufacturer reviewed the photos received and noted that the width of the mesh had been cut from 20 holes to approximately 6-8 holes, which may reduce the tensile strength by over 50 percent.Quality concluded that the non-uniform edges noted on the mesh were due to cutting the mesh prior to use and there were no abnormalities with the mesh.

• 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: 8880325
• MDR Text Key: 153872296
• Report Number: 2125050-2019-00647
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014201022
• Device Catalogue Number: 501420
• Device Lot Number: 6684372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other