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

Catalog Number	0112960
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol perfix plug (device #1).Additional emdrs were submitted to represent the two bard/davol perfix plugs (device #2 and device #3).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug (x3) on (b)(6) 2009 and (b)(6) 2016 (x2).As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug (x3) on (b)(6) 2009 and (b)(6) 2016 (x2).As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2009 - patient was diagnosed with recurrent right inguinal hernia and umbilical hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿right inguinal hernia sac was dissected out.A perfix plug (device #1) was placed into the inguinal side and secure it with suture.Umbilical hernia sac was removed, and the defect was closed with suture.¿ (b)(6) 2016 - patient was diagnosed with two recurrent right inguinal hernia, scar tissue thereby underwent open repair with explant of perfix plug (device #1) and implant of two perfix plug (device #2 and device #3).Per operative notes, ¿two hernia sacs were dissected out.Previously placed perfix plug (device #1) was removed totally.Two perfix plug (device #2 and device #3) was placed into external and inter ring and secure it with suture.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: 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-sep-2008) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no, expiry date, udi no.), d6b (date of explant), g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol - perfix plug (device 1).Additional supplemental emdr's were submitted to represent the bard/davol - perfix plug (device 2), perfix plug (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.H3 other text: not returned.

• 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 ; 4018258495
• MDR Report Key: 11073536
• Report Number: 1213643-2020-11468
• Device Sequence Number: 2875987
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660(17)130930(10)HUSI0519
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 09/30/2013
• Device Catalogue Number: 0112960
• Device Lot Number: HUSI0519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 12/25/2020
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2008
• 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: Disability; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male