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

Catalog Number	0112970
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Scar Tissue (2060)
Date of Event	09/25/2015
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-jul-2013) is considered to be a best estimate.This mdr represents the perfix plug (device 2).An additional emdr was submitted to represent the bard flat mesh (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 received, on (b)(6) 2014 ¿ patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of prefix plug (device 2) and bard flat mesh (device 1).Per op notes, ¿a moderate sized direct defect was noted.A prefix plug (device 2) was placed through the defect beneath the transversalis fascia using suture.A onlay bard flat mesh (device 1) was placed and fastened near the pubic tubercle.¿ on (b)(6) 2015 ¿ patient was diagnosed with chronic right groin pain thereby underwent open repair with the removal of mesh (device 1).Per op notes, ¿there was dense scar tissue at the level of the external oblique.There was a palpable plug (device 2) in the midportion of the direct space which was left in place.A portion of mesh (device 1) was medially slightly buckled and excised.A small defect in the fascia was closed using sutures.A small defect in the fascia was closed using sutures.A triple neurectomy was done by finding iliohypogastric just above the mesh over conjoint tendon and ilioinguinal and genitofemoral nerves.All nerves were transected.¿.

• 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: 24707574
• Report Number: 1213643-2026-00393
• Device Sequence Number: 15964059
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)180728(10)HUXG0306
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 07/28/2018
• Device Catalogue Number: 0112970
• Device Lot Number: HUXG0306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2013
• 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: Disability; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male