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

Catalog Number	0112980
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	04/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hernia recurrence, pain and mesh migration have been alleged post implant of the perfix plug.Based on the event as reported the degree to which the perfix plug used to treat the patient cased or contributed to the patient¿s post operative course cannot be determined.The adverse reactions section of the instructions-for-use supplied with the device lists mesh migration, hernia recurrence and pain as possible complications.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note, the date of event (15-apr-2015) is considered to be a best estimate.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
As alleged, the patient was implanted with perfix plug extra large on (b)(6) 2013 during a hernia repair.Allegedly, the mesh "failed and has caused many problems in the past few years." "it is deteriorated my health.The patches come loose parts of it is missing so therefore it's in body floating around.The rest of it is folded over on itself and has come away from the original repair area.And now there are two hernias underneath the old hernia patch.I have had ct scans and x-rays of this, and it shows clearly what is going on." "i've been suffering for more than 10 years after patch failed.I'm unable to work.I'm in constant pain.I cannot walk more than a city block without cramping or so sore that it becomes impossible.".

• 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: 22019291
• Report Number: 1213643-2025-00380
• Device Sequence Number: 21016125
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(17)171028(10)HUWJ0700
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 10/28/2017
• Device Catalogue Number: 0112980
• Device Lot Number: HUWJ0700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2012
• 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 Sex: Male