MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number 5955600

Device Problem Material Separation (1562)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned and has been evaluated.No manufacturing anomalies were found.Evaluation finds the st coating is separated from areas on the mesh as reported, resulting in a void of the hydrogel barrier.Evaluation identified that the mesh had been hydrated by the user, how long the mesh had been hydrated for is unknown.The instructions-for-use states the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating.The gel is noted to be balling up and pulling away from the mesh; it is known that damage to the hydrogel may occur if the mesh is hydrated longer than the recommended 1-3 seconds.Based on the sample evaluation and the investigation performed, the separation of the hydrogel inadvertently occurred during subsequent handling and preparation for use.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of 120 units released for distribution in september, 2020.

Event Description

As reported, during an unspecified procedure on (b)(6) 2021, a bard/davol ventralight st w/echo 6¿ mesh was hydrated (duration unknown), and placed in the patient.It was noted that the mesh was ¿separating from itself¿ and the surgeon removed this piece of mesh and placed a new piece.There was no reported patient injury.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 11615797
• MDR Text Key: 244384666
• Report Number: 1213643-2021-20066
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Catalogue Number: 5955600
• Device Lot Number: HUEU1430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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