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

Catalog Number 0010302

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Erythema (1840)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

As reported, about two weeks post-implant of the bard/davol ventralex mesh, the patient was diagnosed with mild surrounding erythema which resolved with no treatment required.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.

Event Description

Reported per clinical trial (b)(6): on (b)(6) 2019 - the subject patient underwent primary open midline periumbilical hernia repair procedure during which a bard/davol ventralex hernia patch was placed and sutured with non-bard/davol (pds) suture.Full skin closure was achieved with staples.The patient was discharged to home on (b)(6) 2019.On (b)(6) 2019 - subject patient was diagnosed with mild surrounding erythema.No action taken.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and definitely 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: 14468980
• MDR Text Key: 292356546
• Report Number: 1213643-2022-00279
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• 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: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Catalogue Number: 0010302
• Device Lot Number: HUBW0482
• 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): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 122 KG