MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number 0115310

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, during insertion, the edge of the 3dmax mesh was torn.The subject device was returned for evaluation.Evaluation of the sample finds multiple tears in the edge seal from handling.A larger tear had resulted in a portion of the edge seal tearing away from the mesh.This was not reported as an out of box condition.The mesh fibers at this location have been stretched and/or pulled, which is an indication this portion of the device saw increased forces when gripping the mesh during placement.Based on the sample evaluation and investigation performed, the root cause is determined to be user/device interface while handling the mesh and gripping during attempted placement.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2020.Sample evaluated.

Event Description

It was reported that, during a laparoscopic procedure on (b)(6) 2021, a bard/davol 3dmax mesh was used.It was reported that the mesh tore when gripping in order to wrap it around to place the device.No trocar was used during the procedure.As reported, the mesh was removed and the procedure was completed using a bard/davol 3dmax mid mesh.There was a 5 minute delay in the procedure due to the issue.There was no reported patient injury.

• Brand Name: 3DMAX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 11811712
• MDR Text Key: 250386359
• Report Number: 1213643-2021-20113
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0115310
• Device Lot Number: HUEX1730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other