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

Catalog Number	0112770
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 ¿ patient had bilateral hernia repair with (non-bard/davol) implant of 3x6 inch surgipro polypropylene mesh on the left and a symmetrical 3x6 inch polypropylene mesh on the right (no product identifiers provided and there is no mention of the alleged bard mesh implanted in 2012 as was alleged in the initial legal claim).(b)(6) 2016 ¿ patient had recurrent bilateral inguinal hernia and underwent implant of 2 perfix plugs.Patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent open repair with the implant of perfix plugs (device #1, #2).Per operative notes, ¿on right, ilioinguinal nerve was dissected.A large recurrence was found lateral to cord and a large perfix plug (device #1) was placed into defect and sutured.Then, onlay mesh was sutured to pubic tubercle using sutures.On left, medial recurrence was repaired using a perfix plug and onlay keyhole mesh (device #2) which were placed and sutured to shelving edge of inguinal ligament.¿ attorney alleges mesh migration, mesh shrinkage and pain.
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-sep-2016) is considered to be a best estimate.Note, the date of event (16-jul-2025) is considered to be the best estimate.This emdr was submitted to represent the bard/davol perfix plug (device #2).Additional supplemental emdr represents 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.

• 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: 22746980
• Report Number: 1213643-2025-00735
• Device Sequence Number: 17265373
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)210928(10)HUAW1513
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/05/2025

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: 09/28/2021
• Device Catalogue Number: 0112770
• Device Lot Number: HUAW1513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Male