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

Catalog Number	0112750
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.Patient alleges adverse outcome associated with the hernia mesh used to treat the patient including chronic pain and nerve damage.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the date of event is considered to be a best estimate as (17-apr-2025) based on the date of awareness.This emdr represents the perfix plug (device #2).Additional emdr was submitted to represent the 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
As alleged per patient (pro se): it was alleged that the patient was diagnosed with direct and indirect right inguinal hernia thereby underwent repair with the implant of two prefix plugs (device #1 and #2) on (b)(6) 2011.It was alleged that "patient suffered persistent symptoms, constant dull pain and numbness in the mesh area even when still, sharp pains when leaning against objects, and possible sexual side effects.These issues led to a referral from my original surgeon in 2019 and required pelvic floor therapy from 2021-2022, spanning eight visits.I endure aggravated pain.Daily struggle affecting basic comfort.It was alleged that the "the perfix plugs' design or material is defective, causing chronic pain, nerve damage, and related complications.".
Additional Manufacturer Narrative
No conclusions can be made.Patient alleges adverse outcome associated with the hernia mesh used to treat the patient including chronic pain and nerve damage.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event.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-2011) is considered to be a best estimate.Updated fields: b4, b5, b7, g3, g6, h2, h4, h6, h10, h11 corrected field: b3 (date of event).This supplemental emdr represents the perfix plug (device 2).An additional supplemental emdr was submitted to represent the 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
As alleged per patient (pro se): it was alleged that the patient was diagnosed with direct and indirect right inguinal hernia thereby underwent repair with the implant of two perfix plugs (device 1 and 2) on (b)(6) 2011.It was alleged that "patient suffered persistent symptoms, constant dull pain and numbness in the mesh area even when still, sharp pains when leaning against objects, and possible sexual side effects.These issues led to a referral from my original surgeon in 2019 and required pelvic floor therapy from 2021-2022, spanning eight visits.I endure aggravated pain.Daily struggle affecting basic comfort.It was alleged that the "the perfix plugs¿ design or material is defective, causing chronic pain, nerve damage, and related complications." addendum per additional information provided: (b)(6) 2019 - patient was diagnosed with chronic groin pain thereby underwent medical repair with nerve injection to reduce pain.(b)(6) 2021 to (b)(6) 2022 - patient was diagnosed with chronic groin pain.

• 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: 21967517
• Report Number: 1213643-2025-00358
• Device Sequence Number: 12887517
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)160428(10)HUVD0212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 04/28/2016
• Device Catalogue Number: 0112750
• Device Lot Number: HUVD0212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2011
• 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
• Patient Sex: Male
• Patient Weight: 108 KG