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

Catalog Number	0112750
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Hernia (2240)
Date of Event	02/14/2020
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-jan-2018) is considered to be a best estimate.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) 2010 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿the hernia sac was noted and excised.A bard flat mesh (device 1) was placed and tacked using sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia and left inguinal hernia thereby underwent robotic assisted laparoscopic repair with implant of 3dmax light (device 2 and 3).Per op notes, ¿the hernia sac was noted on the right side and reduced.A 3dmax light (device 2) was placed and sutured.Another hernia sac was noted on the left side and reduced.A 3dmax light (device 3) was placed and sutured.¿ (b)(6) 2018 - patient was diagnosed with recurrent right inguinal hernia with neuralgia thereby underwent open repair with implant of perfix plug (device 4).Per op notes, ¿the hernia sac was noted and the ilioinguinal nerve was emanating under the prior meshes (device 1 and 2) was divided and resected.The prior meshes (device 1 and 2) were noted with tacks.A perfix plug (device 4) was placed and sutured.¿ (b)(6) 2020 - patient was diagnosed with recurrent right inguinal hernia with chronic pain thereby underwent robotic assisted laparoscopic repair with partial excision of bard flat mesh (device 1), 3dmax light (device 2) and perfix plug (device 4).Per op notes, ¿adhesions and scar tissue were excised.The prior meshes (device 1,2 and 4) were partially excised.The genital and femoral branch of genitofemoral and iliohypogastric nerve were excised and sutured.¿ (b)(6) 2021 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with excision of bard flat mesh (device 1), 3dmax light (device 2) and perfix plug (device 4).Per op notes, ¿large thickened pieces of prior meshes (device 1,2 and 4) were excised 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: 23474571
• Report Number: 1213643-2025-01064
• Device Sequence Number: 10229073
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)221228(10)HUCN0308
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: 12/28/2022
• Device Catalogue Number: 0112750
• Device Lot Number: HUCN0308
• 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: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2018
• 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; Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 94 KG