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

Catalog Number	0112970
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Fibrosis (3167)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) -2015 ¿ patient was diagnosed with recurrent incarcerated giant right inguinoscrotal hernia thereby underwent open repair with implant of three perfix plugs (device 1, 2 and 3).Per operative notes, ¿ in the right groin area, a large hernia neck was noted and dissected to the level of pelvic brim.The tissues adherent to the hernia sac was dissected circumferentially.The sac was closed with sutures.Two perfix plugs (device 1 and 2) were placed and sutured together into the deep inguinal ring defect.The floor was reinforced and a large perfix plug (device 3) was placed and sutured it in place in the inguinal floor with sutures.¿ on (b)(6) -2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with removal of prior meshes (device 1, 2 and 3) and implant of synthetic meshes.Per operative notes ¿through the prior right inguinal repair, fibrotic tissues were dissected.Hernia sac and spermatic cord were dissected free from the walls of inguinal canal and reduced.The hernia sac extended into the scrotum and freed from scrotal contents.A piece of incorporated meshes (device 1,2 and 3) was seen loosened and meshes (device 1,2 and 3) deep at the internal ring and pubic tubercle were excised after it was dissected free form the hernia sac.The sac was completely reduced and adhesions to floor of the inguinal canal were freed.A synthetic mesh was placed and secured to the pubic tubercle with sutures.The wound was irrigated and fascia was reinforced with sutures.¿.
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-mar-2015) is considered to be a best estimate.This mdr represents the perfix plug (device 3).An additional supplemental emdr was submitted to represent the perfix plug (device 1).An additional mdr was submitted to represent the perfix plug (device 2).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: 24695685
• Report Number: 1213643-2026-00371
• Device Sequence Number: 18686227
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)200228(10)HUZC0580
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 02/28/2020
• Device Catalogue Number: 0112970
• Device Lot Number: HUZC0580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2015
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 93 KG