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

Catalog Number	0112750
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Hernia (2240)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 6 years post implant of perfix plug, patient was diagnosed with hernia recurrence and inflammation thereby underwent repair.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the perfix plug (device #1).An additional supplemental emdr 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.H3 other text : not returned.
Event or Problem Description
Per additional information provided: (b)(6) 2012 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿a large indirect hernia sac was separated from the cord and was repaired with a small perfix plug (device #1) within the internal ring and a perfix plug (perfix plug onlay) to repair posterior wall.This was anchored to the base of the inguinal ligament laterally and to the conjoined tendon medially." (b)(6) 2013 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #2).Per operative notes, "a large posterior defect was found.A medium perfix plug (device #2) was placed within the defect and the base of the inguinal ligament approximated to the conjoined tendon to repair the posterior wall, anchoring the mesh plug (perfix plug onlay)." (b)(6) 2016 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #3).Per operative notes, "a large indirect hernia sac was found and was dissected up to the internal ring and ligated.A small perfix plug (device #3) was placed to make the internal ring smaller and the posterior wall was reinforced with a perfix patch (perfix plug onlay)." (note, there was no visualization of device #2 during this repair) (b)(6) 2018 - patient was diagnosed with recurrent left inguinal hernia thereby underwent repair.Per operative notes, "a large redundant indirect inguinal sac was reduced off the cord and a portion of a possible old plug (device #1) repair was seen.The hernia sac was reduced at the level of umbilicus, synthetic mesh was then used to wrap around the cord.The right groin with old mesh (device #2) was seen in the direct space with no recurrent hernia.¿ attorney alleges that the patient had mesh migration, nerve damage, other organ perforation, pain, hernia recurrence, repair surgeries and emotional injuries.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 19759937
• Report Number: 1213643-2024-093612
• Device Sequence Number: 12974435
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)161028(10)HUVI2045
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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: 0112750
• Device Lot Number: HUVI2045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2011
• 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: Disability; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 79 KG