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

Catalog Number	5954124
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Bowel Perforation (2668)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a ventral plasty and cholecystectomy procedure on (b)(6) 2022, a 15x15 cm post incisional ventral hernia was found and the patient was implanted with preperitoneal ventralight st mesh.On (b)(6) 2022, the patient presented with secretion of food content from a gastrostomy wound, as well as pain in the left flank, followed by nausea and vomiting of gastric content on 5 occasions, and presence of tachycardia.On (b)(6) 2023, the patient underwent an exploratory laparotomy procedure with placement of a negative pressure system in the surgical injury and the ventralight st mesh was removed.As reported, at the time of the surgery the ventralight st mesh was poorly adhered to the abdominal wall, with abundant cloudy bile secretion noted, purulent fibrin patches in the upper region of the preperitoneal injury.
Additional Manufacturer Narrative
Based on the information provided, the patient treated with a ventralight st mesh experienced medical complications 3 months post implant.Surgical intervention was performed to address secretion of food content from a gastrostomy wound.Surgical intervention included removal of the ventralight st mesh implant.The mesh was noted to be poorly adhered to the abdominal wall 3 months post-op with cloudy bile secretion indicating contaminated mesh.It appears the bowel injury presenting in the postoperative period, caused poor incorporation and contaminated mesh.It appears surgical injury was the cause of the patient complication, with no indication that the use of ventralight st mesh to treat the hernia caused the reported issue.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october 2021.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: 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: 16418516
• Report Number: 1213643-2023-00061
• Device Sequence Number: 14284609
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: 5954124
• Device Lot Number: HUFV1806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 42 YR
• Patient Sex: Female