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

Catalog Number	0112950
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Dysuria (2684)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including pain, trouble during urinating and infection; however, no details have been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.In regards to the infection, the warnings section of the instructions for use (ifu) states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient was implanted with a bard/davol perfix plug on (b)(6)2019.Attorney alleges that the patient sustained serious personal injuries and damages as a result of the defective device.Attorney alleges that from the date of implant of hernia mesh, the patient has experienced extreme pain, trouble urinating, infections and other ongoing problems as a direct result of the hernia mesh.Attorney also alleges that the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including pain, trouble during urinating and infection; however, no details have been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: h.11: this is an addendum to the initial emdr submitted (mdr no.1213643-2021-07613).This supplemental emdr has been submitted to report the corrected implant, event dates and additional event details provided in the second legal claim.No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including disability, nerve entrapment, infections and pain; however, no details have been provided.In regards to the infection, the warnings section of the instructions for use (ifu) states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." should additional information be provided, a supplemental emdr will be submitted.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
Attorney alleges that the patient was implanted with a bard/davol perfix plug on (b)(6) 2019.Attorney alleges that the patient sustained serious personal injuries and damages as a result of the defective device.Attorney alleges that from the date of implant of hernia mesh, the patient has experienced extreme pain, trouble urinating, infections and other ongoing problems as a direct result of the hernia mesh.Attorney also alleges that the device was defective.Addendum per legal claim: attorney alleges that the patient underwent surgery for left inguinal hernia repair with mesh on (b)(6) 2019.Attorney alleges the repair consisted of the following product: bard/davol perfix plug.It is alleged that shortly after recovering from the surgery, the patient began experiencing severe pain, numbness, trouble urinating and ongoing infections in left inguinal/groin area.It is alleged that on (b)(6) 2020, the patient was examined by physicians due to the severe pain and was diagnosed with ilioinguinal nerve entrapment.It is alleged that as a direct and proximate result of the defective perfix plug, it has caused the patient severe pain and permanent bodily injuries, numbness in the left inguinal area, significant mental and physical pain, suffered nerve entrapment and was compelled to undergo additional medical care.Attorney alleges that as a further direct and proximate result, the patient has suffered and sustained, and will continue to suffer and sustain, the following damages: physical pain and suffering, physical disability and mental anguish.It is alleged that the injuries sustained by the patient required medical care and treatment and endure substantial physical discomfort.Attorney also alleges that the device was defective.

• 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: 12509830
• Report Number: 1213643-2021-07613
• Device Sequence Number: 3288563
• Product Code: FTL
• UDI-Device Identifier: 00801741016653
• UDI-Public: (01)00801741016653
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 11/28/2022
• Device Catalogue Number: 0112950
• Device Lot Number: HUBZ1781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2018
• 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: Other; Disability
• Patient Age: 34 YR
• Patient Sex: Male