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

Catalog Number	0112680
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/24/2020
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-oct-2016) is considered to be a best estimate.This emdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the bard perfix plug (device 1).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: (b)(6) 2004 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 1).Per op notes, "an indirect hernia sac was separated from the cord structure.The hernia sac was pushed back through the internal ring and held in place with a perfix plug (device 1).An onlay mesh was placed over the floor of inguinal canal using sutures." (b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the removal of mesh (device 1) and implant of bard flat mesh (device 2).Per op notes, "the mesh was found anterior to the cord.A direct inguinal floor hernia was noted.The mesh (device 1) was adherent to the posterior aspect of the external oblique was freed up and removed.The bard flat mesh (device 2) was placed into defect and sutured.".

• 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: 25215611
• Report Number: 1213643-2026-00652
• Device Sequence Number: 13261379
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)211028(10)HUAX0849
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 10/28/2021
• Device Catalogue Number: 0112680
• Device Lot Number: HUAX0849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2016
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG