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

Catalog Number	0112770
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Scar Tissue (2060); Hernia (2240)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about several months post implant of perfix plug, patient was diagnosed with hernia recurrence, hematoma and scar tissue thereby underwent revision surgery.The instructions-for-use supplied with the device lists hernia recurrence and hematoma as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-nov-2015) is considered to be a best estimate.This emdr represents the bard/davol perfix plug (device #2).An additional supplemental emdr was submitted to represent the bard/davol 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 by patient's attorney: (b)(6) 2016 - patient was diagnosed with large bilateral direct inguinal hernia thereby underwent open repair with implant of three perfix plug (right - device #1, #2 and left - device #3).Per operative notes, ¿the contents of the direct hernia defect on right side were freed and reduced.The hernia sac was stapled and two large perfix plug (device #1, #2) were placed, secured using onlay patch and sutured.The contents of the direct hernia defect on left side were freed up and reduced.A large perfix plug (device #3) was placed, secured with onlay mesh and sutured.¿ (b)(6)2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of perfix plug (device #4).Per operative notes, ¿the indirect hernia sac was identified and separated from the cord structures.Excess sac was trimmed and reduced.A small perfix plug (device #4) was placed and secured with sutures.Too much of scar tissue was present for an onlay patch.¿ attorney alleges that the patient had nerve damage, pain, hernia recurrence and emotional injuries.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 21908871
• Report Number: 1213643-2025-090173
• Device Sequence Number: 4085158
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)201028(10)HUZK0650
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 10/28/2020
• Device Catalogue Number: 0112770
• Device Lot Number: HUZK0650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2015
• 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: 58 YR
• Patient Sex: Male