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

Catalog Number	0112650
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Necrosis (1971)
Date of Event	09/23/2015
Type of Reportable Event	Serious Injury
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.Note, the manufacturing date (15-feb-2012) is considered to be a best estimate.This emdr was submitted to represent the bard flat mesh (device #1).An additional supplemental emdr submitted to represent the bard flat mesh (device #2).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.
Event or Problem Description
Per information provided: on (b)(6) 2015 ¿ patient was diagnosed with incarcerated left inguinal hernia thereby underwent open repair with the implant of bard flat mesh (device #1, #2).Per op notes, ¿the bard flat mesh (device #1) was sewn in place along the shelving border laterally and medially tacked to transversalis fascia, the second piece of bard flat mesh (device #2) was added to length of defect.¿ on (b)(6) 2015 ¿ patient had fluid collection in left groin thereby underwent incision and drainage of left groin wound.On (b)(6) 2015 ¿ patient was diagnosed with left groin abscess thereby underwent open repair with removal of meshes (device #1, #2).Per op notes, ¿there was some necrotic fat and incorporated mesh (device #1, #2) which were excised to its fullest extent.¿.

• 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: 22381754
• Report Number: 1213643-2025-00551
• Device Sequence Number: 18537461
• Product Code: FTL
• UDI-Device Identifier: 00801741016509
• UDI-Public: (01)00801741016509(17)170228(10)HUWB0251
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• 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: 02/28/2017
• Device Catalogue Number: 0112650
• Device Lot Number: HUWB0251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2012
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male