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

Catalog Number	0112950
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	11/30/2018
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-sep-2011) is considered to be a best estimate.This emdr represents the bard perfix plug (device #2).An additional supplemental emdr was submitted to represent the bard 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: (b)(6) 2013 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device #1 & #2).Per operative notes, ¿a direct hernia sac in the right inguinal region was identified and reduced.A small perfix plug (device #1) was placed using prolene sutures.A direct hernia sac in the left inguinal region was identified and reduced.A perfix plug (device #2) was placed using prolene sutures.¿ (b)(6) 2018 - patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax (device #3 & #4).Per operative notes, ¿a direct hernia defect was identified in the right inguinal region superior to pubic tubercle and reduced.The adhesions and scar tissue of prior mesh was taken down.A 3dmax (device #3) was placed and tacked.A large direct hernia defect was identified in the left inguinal region and reduced.The prior mesh was identified and adherent to cord structures were taken down.A 3dmax was placed and tacked.¿.

• 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: 22370498
• Report Number: 1213643-2025-00543
• Device Sequence Number: 18149036
• Product Code: FTL
• UDI-Device Identifier: 00801741016653
• UDI-Public: (01)00801741016653(17)161028(10)HUVI2049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 10/28/2016
• Device Catalogue Number: 0112950
• Device Lot Number: HUVI2049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2011
• 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: 75 YR
• Patient Sex: Male