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	Adhesion(s) (1695); Inflammation (1932); Scar Tissue (2060)
Date of Event	06/18/2014
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-jun-2013) is considered to be a best estimate.This emdr represents the bard perfix plug (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) 2014 ¿ patient was diagnosed with chronic right groin pain, entrapment of ilioinguinal nerve, left inguinal hernia thereby underwent open repair with the implant of perfix plugs (left ¿ device 1, 2).Per op notes, ¿on left side, ilioinguinal nerve was excised.There was a laxity and weakness of the inguinal floor.A piece of perfix plug (device 1, 2) were placed over the inguinal floor and secured to conjoint tendon, shelving edge using sutures.On right side, the planes were consistent with scarring and infection.The nerve and portion of old mesh was excised.The remainder of mesh was incorporated into surrounding tissue.The moderate sized defect was noted.¿ (note: the mesh removed from right inguinal side in this procedure was unknown) (b)(6) 2014 ¿ patient had inflammation, scar tissue, adhesion thereby underwent open repair with the removal of meshes (device 1, 2).Per op notes, ¿on left side, scar tissue was freed.The underlying mesh (device 1, 2) was excised from adherent scar tissue.On right groin, scar tissue was excised.The unknown mesh was retracted in anterior fashion.The unknown mesh and overlying balled up mesh near pubic tubercle was removed.¿.

• 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: 24266564
• Report Number: 1213643-2026-00085
• Device Sequence Number: 18647233
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)180628(10)HUXF0194
• 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: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: 06/28/2018
• Device Catalogue Number: 0112970
• Device Lot Number: HUXF0194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/05/2026
• 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: 20 YR
• Patient Sex: Male