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

Catalog Number	0112970
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Fibrosis (3167)
Date of Event	02/08/2018
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-may-2015) is considered to be a best estimate.This 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
Per information provided: (b)(6) 2015 ¿ patient was diagnosed with left inguinal hernia thereby underwent laparoscopic converted into open repair with implant of perfix plug (device #1).Per operative notes, a small indirect hernia was dissected and reduced.A perfix plug (device #1) was placed into the inguinal ring and secured with sutures.¿ (b)(6) 2015 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of perfix plug (device #2).Per operative notes, ¿the indirect hernia was identified and reduced.The perfix plug (device #2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with chronic left inguinal pain thereby underwent open repair with removal of mesh (device #1) and inguinal necrectomy.Per operative notes, ¿the scar tissue was seen adherent to the underlying mesh (device #1).The adhesions between the mesh and conjoined tendons were dissected.The mesh (device #1) was removed.The nerve structures in the superior edge of mesh were removed¿ (b)(6) 2018 - patient was diagnosed with chronic right inguinal pain thereby underwent open repair with removal of mesh (device #2).Per operative notes, ¿due to extensive scarring and fibrosis the ilioinguinal and genitofemoral nerve were not visualized.The perfix plug (device#2) was removed from the surrounding tissues.The small indirect hernia was repaired with sutures.¿.

• 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: 22139601
• Report Number: 1213643-2025-00430
• Device Sequence Number: 7023167
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)200528(10)HUZE1460
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 05/28/2020
• Device Catalogue Number: 0112970
• Device Lot Number: HUZE1460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2015
• 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: 30 YR
• Patient Sex: Female