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

Catalog Number	0112750
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	07/01/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: on (b)(6) 2006 - patient was diagnosed with bilateral inguinal and umbilical hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device #1 - left inguinal), synthetic mesh (right inguinal) and ventralex mesh (device #2 - umbilicus).Per operative notes, ¿the hernia defect of umbilicus was identified and reduced.A ventralex mesh (device #2) was placed and sutured.Direct hernia defects were identified in both inguinal regions were reduced.A 3dmax mesh (device #1) on the left side and synthetic mesh on the right side were placed and sutured.¿ on (b)(6) 2008 - patient was diagnosed with recurrent left inguinal hernia and pain thereby underwent laparoscopic repair with implant of perfix plug (device #3).Per operative notes, ¿the direct hernia defect was identified where the prior mesh was separated.The hernia defect was reduced.A perfix plug was placed and sutured.¿ on (b)(6) 2009 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of perfix plug (device #4).Per operative notes, ¿a small hernia defect was identified and reduced.A perfix plug (device #4) was placed and sutured.¿.
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 emdr represents the perfix plug (device #3).An additional supplemental emdr was submitted to represent the 3dmax mesh (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.H3 other text: not returned.

• 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 ; 4018258495
• MDR Report Key: 22035247
• Report Number: 1213643-2025-090209
• Device Sequence Number: 8814605
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(10)43LPD070
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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 Catalogue Number: 0112750
• Device Lot Number: 43LPD070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 77 KG