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	04/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2010 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device 1, 2, 3, 4 and 5).Per op notes, ¿an incision was made from the pubic tubercle to mid inguinal point.A small defect hernia where preperitoneal fat bulging out was identified and it was the site of the incisional hernia from the appendix incision on the right from which the fat was excised.It was repaired with a perfix plug (device 1) and secured with sutures.The direct and indirect hernia sac was identified and the indirect hernia sac was ligated on itself and pushed in the preperitoneal space.And plugged with a same plug (device 2 and 3) on right and surrounding fascia was stabilized with a suture.The mesh was sutured to the shelving edge of inguinal ligament.The left sided hernia was the same except for the hernia component of the appendiceal incision.The testis were pulled back in the scrotum.A perfix plug (device 4 and 5) were placed in the left and secured with sutures.¿ on (b)(6) 2015 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of ventralex mesh (device 6).Per op notes, ¿a curvilinear incision was made below the umbilicus.The hernia sac was identified and contents were removed.The sac was ligated with sutures, a ventralex mesh (device 6) was placed and secured with sutures.¿ on (b)(6) 2016 ¿ patient was diagnosed with recurrent left sided inguinal hernia and persistent pain in left groin thereby underwent open repair with excision of perfix plug (device 4 and 5).Per op notes, ¿a skin incision was made.The hernia site was identified.Some recurrent hernia was noted and removed the old mesh (device 4 and 5) which was painful.The hernia was reduced with sutures.The ilioinguinal was identified and inguinal scar tissue was divided for frozen section analysis.Skin was closed 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-oct-2009) is considered to be a best estimate.This emdr represents the bard/davol perfix plug (device 5).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (device 4) and mesh ¿ ventralex (device 6).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: 24834691
• Report Number: 1213643-2026-00461
• Device Sequence Number: 9187324
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)141228(10)HUTL0202
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 12/28/2014
• Device Catalogue Number: 0112780
• Device Lot Number: HUTL0202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2009
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 87 KG