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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Sepsis (2067); Peritonitis (2252); Bowel Perforation (2668)
Date of Event	08/04/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2014 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with the implant of two bard flat mesh (device #1 ¿ left, device #2 ¿ right).Per op notes, ¿on left, bard flat mesh (device #1) was placed into defect and secured using tacks.On right, bard flat mesh (device #2) was positioned against coverage of the direct and indirect areas of defect and secured using tacks.¿ (b)(6) 2014 ¿ patient was diagnosed with closed loop obstruction with perforated small bowel thereby underwent open repair with the removal of mesh (device #1, #2).Per notes, ¿there was a large amount of free fluid within the peritoneum along with succus.Dense adhesions of the small bowel to the previously placed mesh (device #1, #2) in the left lower quadrant were taken down.There was one area of perforation in the small bowel in the pelvic region.Some areas of small bowel was incorporated to the mesh.There was small bowel adherent to the fascia mesh (device #1, #2) posteriorly and anteriorly were taken down.The patient was getting septic and for further resuscitation taken to the icu.¿ (b)(6) 2014 ¿ patient underwent small bowel resection and end to end anastomosis.(b)(6) 2014 ¿ patient underwent abdominal closure.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This emdr was submitted to represent the bard flat mesh (device #2).An additional supplemental emdr was submitted to represent the bard flat mesh (device #1).Note, the manufacturing date (15-dec-2012) is considered to be a best estimate.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 FLAT 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: 22334629
• Report Number: 1213643-2025-00523
• Device Sequence Number: 18390851
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)180128(10)HUWL1300
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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: 01/28/2018
• Device Catalogue Number: 0112720
• Device Lot Number: HUWL1300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2012
• 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: Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male