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

Catalog Number	0112760
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/25/2019
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-oct-2012) is considered to be a best estimate.This emdr represents the bard perfix plug (device #2).Additional supplemental emdr and emdr were submitted to represent the bard modified kugel patch (device #1) and bard flat mesh (device #3).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) 2013 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with the implant of modified kugel patch (device #1 ¿ right), perfix plug (device #2 - left), bard mesh (device #3 - left).Per op notes, ¿on right, the entire inguinal floor was reinforced by a piece of modified kugel patch (device #1) and sutured from the shelving edge of the inguinal ligament to the internal oblique fascia.On left, similar procedure was carried out as right side with the implant of perfix plug (device #2) and bard flat mesh (device #3).¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with the implant of bard soft mesh (device #4).Per op notes, ¿on the left side, the patient was noted to have mesh (device #2, #3) with prior open hernia repair extruding through the internal ring.On the right side, patient had small defect.A bard soft mesh (device #4) was placed in a u formation around the vessels in vas deferens using a sorbafix tacker.¿ (b)(6) 2019 ¿ patient underwent removal of left inguinal nerve.(note: there is no op notes provided in medical record).

• 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: 22396261
• Report Number: 1213643-2025-00557
• Device Sequence Number: 4799681
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)171128(10)HUWJ2037
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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: 11/28/2017
• Device Catalogue Number: 0112760
• Device Lot Number: HUWJ2037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2012
• 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; Disability
• Patient Age: 43 YR
• Patient Sex: Male