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

Catalog Number 0117014

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, the bard soft mesh pre-shaped tore during implant.The subject device was not returned for evaluation, however a photo was provided.Evaluation of the photo finds that the surgeon tailored the mesh creating a v shape which shows cutting from the edges inward and then pulling of the mesh into the v shape.It also appears the doctor created a keyhole above the v shape of the mesh.Based on the photo evaluation and investigation performed, the mesh tearing cannot be confirmed as the mesh was tailored for use.Hence, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2020.The instructions-for-use (ifu) supplied with the mesh adequately describes the proper technique for implantation.The precautions section of the ifu states, "intact bard soft mesh exhibits high burst and tensile strength.However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point." not returned.

Event Description

As reported, during lichtenstein herniorrhaphy on (b)(6) 2022, the bard soft mesh was attempted to implant into the patient.As reported, the surgeon tried to pick the mesh up and the mesh broke with a hole just with a finger under it.It was also reported that there was no tear/hole on the mesh identified when opening the package or prior to insertion into the patient.As reported, the surgeon used another bard soft mesh to complete the procedure and there was no reported patient injury.

• Brand Name: BARD SOFT MESH
• 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: 14014452
• MDR Text Key: 288797107
• Report Number: 1213643-2022-00134
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030918
• UDI-Public: (01)00801741030918
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0117014
• Device Lot Number: HUEX1052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 56 KG