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

Catalog Number 5950009

Device Problem Material Separation (1562)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

As reported, during an open umbilical hernia repair procedure on (b)(6) 2022, the surgeon used a bard/davol ventralex st mesh.When the surgeon cut the straps "the mesh seemed to fall apart." it was reported that the surgeon used another piece to complete the case.There was reported patient injury.

Manufacturer Narrative

The subject device was returned for evaluation.Review of the subject device and photo provided finds that the positioning straps are cut off as intended to be once the device is positioned.Evaluation of the sample finds there is minor mesh fraying on the positioning pocket at the location of the positioning straps as a result of manipulation and removal of the positioning straps.The positioning pocket and the pod ring around the mesh are intact and well formed.No manufacturing anomalies found.Based on the sample evaluation and investigation performed, the mesh remains intact with no anomalies found.The allegation that the mesh ¿seemed to fall apart¿ cannot be confirmed.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 387 units released for distribution in march, 2021.Sample evaluated.

• Brand Name: VENTRALEX ST
• 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: 14989129
• MDR Text Key: 295809087
• Report Number: 1213643-2022-00513
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: 5950009
• Device Lot Number: HUEZ1740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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