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

Catalog Number 0010303

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Seroma (2069); Post Operative Wound Infection (2446)

Event Date 11/06/2011

Event Type  Injury  

Manufacturer Narrative

As reported post implant of the ventralex mesh, the patient developed surgical site infection, underwent percutaneous aspiration of infectious seroma and prescribed with oral antibiotics.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and possibly related to the procedure, however, based on the information provided, no conclusion can be made.Post operative infection and seroma formation are known inherent risks of surgery.The instructions-for-use (ifu) supplied with the device lists infection and seroma as possible complications.In regards to infection, the warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the patch.An unresolved infection may require removal of the device." a lot number was not provided, without a lot number a review of the manufacturing records could not be conducted.Not returned - remains implanted.

Event Description

Reported per clinical trial (b)(4): on (b)(6) 2011 - subject patient underwent open midline umbilical repair and lysis of adhesions during which a bard/davol ventralex hernia patch was implanted with mechanical sutures.Fascia and full skin closure was achieved using non-bard/davol prolene and surgical glue.The patient was discharged to home on (b)(6) 2011.On (b)(6) 2011 - subject patient was diagnosed with surgical site infection, was treated with oral antibiotics and percutaneous aspiration of infectious seroma at the surgical site in the clinic.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.

• Brand Name: MESH-VENTRALEX
• 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: 14434827
• MDR Text Key: 292028335
• Report Number: 1213643-2022-00237
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0010303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 97 KG