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

Catalog Number UNKAA030

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Perforation (2001); Obstruction/Occlusion (2422); Abdominal Cramps (2543)

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including perforation, bowel obstruction, adhesions and pain.The instructions-for-use (ifu) supplied with the device lists adhesions as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard flat mesh (device #2).An additional emdr was submitted to represent the bard/davol ventralight st mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Per patient (as pro-se): "in 2016 or 2017 of (b)(6) i had a(n) inguinal hernia repair surgery"."i had these surgeries and i was not feeling right after i had it.I had massive pain which is to be expected, but i still have pain right now! i have bowel obstruction, severe stomach cramps, adhesion to tissue and organs and other problems.The new permanent hernia mesh includes bard mesh (bard flat mesh) or the ventralight st mesh.The bowel obstruction, internal pain, puncture of adjacent tissue organs, adhesion to tissue organs.It's bard's mesh (bard flat mesh)!".

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 15065343
• MDR Text Key: 296228318
• Report Number: 1213643-2022-95505
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2022
• 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): Life Threatening
• Patient Sex: Male