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

Catalog Number	0112760
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Unspecified Infection (1930)
Date of Event	08/26/2015
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.This emdr represents the bd perfix plug (device 2).An additional supplemental emdr was submitted to represent the bd 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) 2006 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of two perfix plugs (device 1 and 2).Per op notes, "two perfix plugs (device 1 and 2) were placed on the floor of the inguinal canal using sutures." (b)(6) 2015 - patient was diagnosed with infected mesh with small bowel fistula to abscess thereby underwent repair with removal of prevesical abscess and mesh (device 1 and 2) and small bowel resection.Per op notes, "a large abscess cavity was identified.A portion of mesh from prior inguinal hernia had pulled free, this mesh had eroded.All mesh had been excised.".

• 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 ; 8005566756
• MDR Report Key: 23484554
• Report Number: 1213643-2025-01068
• Device Sequence Number: 10559055
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(10)43DQO606
• 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: 2006
• 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): 11/04/2025

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 Catalogue Number: 0112760
• Device Lot Number: 43DQO606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 65 YR
• Patient Sex: Male