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

Catalog Number	0112970
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	07/25/2019
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-apr-2014) is considered to be a best estimate.This mdr represents the perfix plug (device 3).An additional supplemental emdr was submitted to represent the perfix plug (device 1) and perfix plug (device 2).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: on (b)(6) 2018- patient was diagnosed with direct right inguinal hernia, thereby underwent open repair with implant of perfix plug (device 1).Per op notes, ¿a direct right inguinal hernia was noted and dissected.A perfix plug (device 1) was placed on the floor and sutured¿.On (b)(6) 2018 - patient was diagnosed with recurrent right inguinal hernia, thereby underwent open repair with implant of perfix plugs (device 2 and 3).Per op notes, ¿scar tissue was identified.Recurrent hernia was found attached laterally to the previous placed perfix plug (device 1).There was a large direct recurrent inguinal hernia which was then dissected.A perfix plugs (device 2 and 3) were placed on the defects and was sutured¿.On (b)(6) 2019- patient was diagnosed with recurrent right inguinal hernia, thereby underwent open repair with explant of perfix plugs (device 1, 2 and 3) and implant of perfix plug (device 4).Per op notes, ¿excessive scarring was noted and dissected.Two rolled meshes one attached to lateral portion of urinary bladder was identified.Perfix plugs (device 1, 2 and 3) were excised.Perfix plug (device 4) was placed and sutured.¿.

• 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: 23897314
• Report Number: 1213643-2025-01276
• Device Sequence Number: 11900268
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)190528(10)HUYD1704
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 05/28/2019
• Device Catalogue Number: 0112970
• Device Lot Number: HUYD1704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2014
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 95 KG