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

Catalog Number	0112780
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	03/26/2010
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-2007) is considered to be a best estimate.This mdr represents the perfix plug (device 4).Additional supplemental emdr's were submitted to represent the perfix plugs (device 1 and 2).An additional emdr was submitted to represent the 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.
Event or Problem Description
Per information provided: on (b)(6) 2007 ¿ patient was diagnosed with incarcerated left inguinal hernia thereby underwent open repair with implant of four perfix plugs (device 1, 2, 3 and 4).Per operative notes, ¿a large inguinoscrotal hernia in the left side which was chronically incarcerated was noted.The hernia was reduced and excised.Three extra-large perfix plug was sutured together to the inguinal ligament inferiorly and an another perfix plug (device 4) was placed in the reverse with end under the lateral edge of the transversalis arch and secured with sutures and tacks.¿ on (b)(6) 2010 - patient was diagnosed with recurrent left inguinal hernia and pain thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿a large recurrent left inguinal scrotal hernia was noted.The midline fascia containing hernia contents and scar tissues were excised.The sac was stuck to the pieces of prior meshes (device 1,2,3 and 4) in the scrotum.The sac was reduced off the palpable meshes and a large sheet of synthetic mesh was placed over the defect and secured to the pubic tubercle with sutures.The midline fascia was closed using sutures.¿.

• 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: 24322270
• Report Number: 1213643-2026-00117
• Device Sequence Number: 13263176
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)120528(10)HURE0503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 05/28/2012
• Device Catalogue Number: 0112780
• Device Lot Number: HURE0503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2007
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 168 KG