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

Catalog Number	0112970
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	08/05/2020
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-may-2019) is considered to be a best estimate.This emdr represents perfix plug (device #2).An additional supplemental emdr was submitted to represent 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 medical records: (b)(6) 2019- patient was diagnosed with symptomatic inguinal hernia thereby underwent laparoscopic left inguinal herniorrhaphy with repair of both direct & indirect defects using two perfix plugs & patch (device #1 & #2).Per operative notes, ¿an incision was made in the left inguinal region.The hernia sac was dissected away.A perfix plug (device #1) was placed into the internal ring.There was also a direct defect for which a perfix plug & patch (device #2) was placed around the cord structures using sutures.¿ (b)(6) 2020- patient was diagnosed with recurrent left inguinal hernia thereby underwent repair.Per operative notes, ¿incision was made through the previous left inguinal incision.Dissection was carried through dense scar.Noted a small hernia defect noted along the cord structures.For this, a polypropylene mesh plug was able to be placed, and it was able to be secured.¿.
Event or Problem Description
Addendum per additional information provided: (b)(6) 2019- patient was diagnosed with symptomatic inguinal hernia thereby underwent laparoscopic left inguinal herniorrhaphy with repair of both direct & indirect defects using two perfix plugs & patch (device #1 & #2).Per operative notes, ¿an incision was made in the left inguinal region.The hernia sac was dissected away.A perfix plug (device #1) was placed into the internal ring.There was also a direct defect for which a perfix plug & patch (device #2) was placed around the cord structures using sutures.¿ (b)(6) 2020- patient was diagnosed with recurrent left inguinal hernia thereby underwent repair.Per operative notes, ¿incision was made through the previous left inguinal incision.Dissection was carried through dense scar.Noted a small hernia defect noted along the cord structures.For this, a polypropylene mesh plug was able to be placed, and it was able to be secured.¿.
Additional Manufacturer Narrative
Addendum #1: this supplemental emdr is submitted to document additional information provided.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-2019) is considered to be a best estimate.Addendum #2: this supplemental emdr is submitted to document additional information provided.Updated fields: d3, e.1 (complainant name, complainant phone #, complainant facility, complainant e-mail address), g6, h2, h10.This supplemental emdr represents perfix plug (device #2).An additional supplemental emdr was submitted to represent 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.Not returned.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGIAL 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 ; 4018258495
• MDR Report Key: 21950052
• Report Number: 1213643-2025-090192
• Device Sequence Number: 8802643
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)240528(10)HUDS1699
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 05/28/2024
• Device Catalogue Number: 0112970
• Device Lot Number: HUDS1699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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: 57 YR
• Patient Sex: Male