MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number 0123680

Device Problem Expiration Date Error (2528)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

As reported, during an unknown procedure, the surgeon implanted a bard/davol composix e/x mesh which had expired on (b)(6) 2022 in the patient.As reported, the mesh was removed once noticed before closing the patient.The procedure was completed by using another implant with a valid expiration date.There was no reported patient injury.

Manufacturer Narrative

As reported, an expired bard/davol composix e/x mesh was inadvertently implanted into the patient and removed once noticed.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error with no malfunction of the device.No patient injury was reported.The subject device is not returned for evaluation.Additional information has been requested.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 58 units released for distribution in may, 2017.Note, the date of event are estimated based on the information provided.Not returned.

• Brand Name: COMPOSIX MESH E/X
• 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: 14876548
• MDR Text Key: 295336143
• Report Number: 1213643-2022-00483
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002684
• 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: 06/17/2022

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 Expiration Date: 03/28/2022
• Device Catalogue Number: 0123680
• Device Lot Number: HUBR0356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• 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