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

Catalog Number	0117011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Inflammation (1932); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent right hernia repair surgery with the implant of bard flat mesh on (b)(6) 2010.It was reported that on (b)(6) 2012, the patient suffered the development of chronic pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence and further reparative surgeries.And polypropylene suture was used.It was further reported that on (b)(6) 2018 the patient was implanted with bard soft mesh and subsequent to the latter surgery, the plaintiff has continued to suffer from chronic pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence which resulted in the patient requiring various additional surgeries.It is also alleged that the device was defective.
Additional 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 hernia recurrence, bowel obstruction, inflammation and additional surgeries.The instructions-for-use supplied with the device lists hernia recurrence and inflammation as possible complications.A review of the manufacturing records was performed and found the lot was manufactured to specification.Note, the manufacturing date (15-sep-2015) is considered to be a best estimate.The date of event is considered to be a best estimate as (08-aug-2025) based on the date of awareness.This emdr represents the bard soft mesh (device 2).An additional emdr was submitted to represent the bard flat mesh (device 1).Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARD SOFT 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: 22858260
• Report Number: 1213643-2025-00782
• Device Sequence Number: 15803587
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)200928(10)HUZI1955
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 09/28/2020
• Device Catalogue Number: 0117011
• Device Lot Number: HUZI1955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2015
• 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
• Patient Age: 37 YR
• Patient Sex: Male