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

Catalog Number	0112960
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Impaired Healing (2378)
Date of Event	11/22/2016
Type of Reportable Event	Death
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2011 - patient was diagnosed with incisional umbilical hernia thereby underwent repair with implant of non-bard/bd proceed mesh.Per op notes, ¿the umbilical defect was closed then synthetic mesh was placed, secured using sutures and tacks.¿ (b)(6) 2011 - patient underwent wound exploration and removal of infected mesh.Per op notes, ¿the purulent fragmented mesh that became loose in subcutaneous tissues was removed.¿ (b)(6) 2016 - patient was diagnosed with pantaloon right direct and indirect inguinal hernias thereby underwent open repair with implant of two perfix plug (device #1 & #2).Per op notes, ¿the pantaloon right direct and indirect inguinal hernias was repaired using two perfix plug (device #1 & device #2).An overlay patch as well as placed and secured using sutures.¿ (b)(6) 2016 - patient was diagnosed with chronic non-healing wound and infected mesh thereby underwent repair with mesh explant.Per op notes, ¿the purulent material from chronic groin abscess cavity was aspirated.The 2 mesh plugs with covering mesh (device #1 & #2) adherent to surrounding structure were removed.¿.
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.Attorney alleges wrongful death of the patient.No information was provided regarding patient¿s death in the medical records provided to date.No autopsy report, or death certificate have been provided.Note, the manufacturing date (15-sep-2015) is considered to be a best estimate.This emdr represents the perfix plug (device #2).Additional supplemental emdr's were submitted to represent the ventralex and 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.

• Brand Name: PERFIX PLUG
• 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 ; 4018258495
• MDR Report Key: 22018646
• Report Number: 1213643-2025-090207
• Device Sequence Number: 9504813
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660(17)200928(10)HUZI1905
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: 0112960
• Device Lot Number: HUZI1905
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Death
• Patient Age: 77 YR
• Patient Sex: Male