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

Catalog Number	0117050
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	04/22/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2013 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix light plugs (device 1, device 2).Per op notes, ¿there was a modest-sized direct defect from previous surgeries.The large perfix light plug (device 1) was inserted into the defect and secured around the circumference with sutures.A small perfix plug (device 2) was inserted at the level of the femoral opening to eliminate recurrence and an onlay patch was laid over the inguinal floor using sutures.¿ on (b)(6) 2014 - patient was diagnosed with recurrent incarcerated right inguinal hernia thereby underwent open repair with the removal of meshes (device 1, 2).Per op notes, ¿scar tissue and mesh were noted.The mesh (device 1, 2) had pulled away from shelving edge and medial location with recurrence.The meshes (device 1, 2) were excised.A new piece of synthetic mesh was sewn into pubic tubercle using sutures.¿.
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-2012) is considered to be a best estimate.This mdr represents the perfix plug light (device 2).An additional supplemental emdr was submitted to represent the perfix plug light (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 LIGHT
• 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: 24455565
• Report Number: 1213643-2026-00226
• Device Sequence Number: 15858243
• Product Code: FTL
• UDI-Device Identifier: 00801741030949
• UDI-Public: (01)00801741030949(17)170828(10)HUWG1512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 02/16/2026

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: 08/28/2017
• Device Catalogue Number: 0117050
• Device Lot Number: HUWG1512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2012
• 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: 53 YR
• Patient Sex: Female