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

Catalog Number 0115322

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

As reported, during an unknown procedure on (b)(6) 2022, the bard/davol 3dmax mesh (device #1) tore upon removal from the package.As reported, the mesh was not used and another bard/davol 3dmax mesh (device #2) was opened, which tore as well.The procedure was completed using an unknown mesh.There was no reported patient injury.

Manufacturer Narrative

As reported, the 3dmax mesh was noted to be torn upon removed from package.The subject device was returned for evaluation.Evaluation of the sample finds that there is visible frays/tearing in the edge seal of the mesh with one tear travelling slightly into the mesh fibers.Such markings are consistent with rolling the mesh for fixation and the found edge seal and mesh tearing condition is not indicative of the as manufactured condition.Based on the sample evaluation and investigation performed, the root cause is most likely the result of handling and inadvertently occurred during user/device interface while in preparation to deploy the mesh.To date, this is the only reported complaint for this manufacturing lot.This emdr represents the bard/davol 3dmax mesh (device #2).An additional emdr was submitted to represent the bard/davol bard/davol 3dmax mesh (device #1).Sample evaluated.

• 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: 14580372
• MDR Text Key: 293456681
• Report Number: 1213643-2022-00371
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0115322
• Device Lot Number: HUFX0827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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