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

Catalog Number	0112960
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/20/2002
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.This emdr represents the bard perfix plug (device 2).Additional supplemental emdr and emdr were submitted to represent the bard perfix plug (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: on (b)(6) 2001, patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 1).Per operation notes, "an incision was made in the left groin, a perfix plug (device 1) was placed using prolene sutures." on (b)(6) 2002, patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 2) and umbilical hernia repair with marlex mesh.Per operation notes, "an incision was made in the left groin, the previous mesh plug (device 1) was found and placed an another perfix plug (device 2).Attention to the umbilicus, the umbilicus was repaired with unknown marlex mesh." on (b)(6) 2002, patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of bard flat mesh (device 3).Per operation notes, "an incision was made in the old wound, and dissection was carried out.A bard flat mesh (device 3) was placed." (note: the previously placed perfix plug (device 2) was not seen during this procedure).On (b)(6) 2002, patient was diagnosed with recurrent left inguinal hernia thereby underwent repair the implant of synthetic mesh.Per operation notes, "a synthetic mesh was placed." on (b)(6) 2003, patient was diagnosed with recurrent left inguinal hernia thereby underwent repair with the implant of synthetic mesh.Per operation notes, "a synthetic mesh was placed.".

• 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: 23542259
• Report Number: 1213643-2025-01091
• Device Sequence Number: 9283818
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660(10)43KLD162
• 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: 2002
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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 Catalogue Number: 0112960
• Device Lot Number: 43KLD162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 47 YR
• Patient Sex: Male