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

Catalog Number	0112970
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/02/2013
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.This mdr represents the perfix plug (device 2).An additional supplemental emdr was submitted to represent the 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.
Event or Problem Description
Per information provided: on (b)(6) 2008 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of two perfix plugs (device 1 and 2).Per operative notes, "in the right inguinal area, the large direct hernia with sac was dissected down to the hernia with peritoneal fat.The hernia sac and bladder wall was reduced, and fascia was closed with sutures.A large perfix plug (device 1) was placed over the inguinal floor of the cavity and secured with sutures.In the left side, the direct defect with spermatic cord was dissected and another large perfix plug mesh (device 2) was placed and secured it to aponeurosis fascia.The fascia was closed and secured it with sutures." on (b)(6) 2013 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with removal of old mesh (device 1) and implant of bard flat mesh (device 3).Per operative notes, "through the prior repair, the scar tissues were excised.A direct hernia defect with old mesh (device 1) pulled away superiorly and medially was noted.The mesh (device 1) was mobilised and dissected from the surrounding tissues.The peritoneum was closed with sutures and bard flat mesh (device 3) was placed over the defect in the floor of the canal and sutured inferiorly to the inguinal ligament." on (b)(6) 2013 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with removal of old mesh (device 2) and implant of bard flat mesh (device 4).Per operative notes, "in the left groin, the indirect hernia had recurred, and mesh (device 2) had pulled away from the inguinal ligament inferiorly.The mesh (device 2) was dissected away from the cord structures at the level of internal ring and excised.The sac was reduced and dissected away.The bard flat mesh (device 4) was placed over the defect and sutured inferiorly to the inguinal ligament.The fascia was closed and secured with 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: 24766472
• Report Number: 1213643-2026-00428
• Device Sequence Number: 18466159
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(10)43HQD159
• 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: 2008
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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 Catalogue Number: 0112970
• Device Lot Number: 43HQD159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 53 YR
• Patient Sex: Male