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

Catalog Number 0116321

Device Problem Off-Label Use (1494)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

As reported, during an inguinal hernia repair on (b)(6) 2022, the right-sided bard / davol 3dmax mid mesh was mistakenly implanted on the patient's left side which was marked for a right-side repair.It was reported that the surgeon flipped the mesh over, so the medial marker was still pointed medially.As reported, the surgeon chose to leave the mesh implanted.There was no reported patient injury.

Manufacturer Narrative

As reported, during an inguinal hernia repair, a right-sided 3dmax mid mesh was mistakenly implanted on the patient's left side.The 3dmax mid mesh is an anatomically shaped implant intended for left/right side inguinal repair.The mesh has a medical marker to assist in placing in the appropriate location.As reported the surgeon flipped the mesh so that the anatomical shape was inverted to fit the anatomy and the medial marker was pointed medially.Based on the information provided this is a use related error with no malfunction of the device.This products packaging (inner and outer) is labeled for its intended use (left/right).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) released for distribution in may, 2022.

• Brand Name: 3DMAX MID
• 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: 15624511
• MDR Text Key: 302403683
• Report Number: 1213643-2022-00651
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0116321
• Device Lot Number: HUGRAB09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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