MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0113710
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360)
Date of Event	03/02/2021
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 disability, pain and subsequent surgical intervention.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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 pre-shaped mesh with keyhole (the product).It is alleged that on (b)(6) 2012, the patient was implanted with the product in the course of a left inguinal hernia repair surgery.It is alleged that further to the implantation with the product, the patient suffered the development of chronic pain.It is alleged that on (b)(6) 2021, the patient underwent corrective revision surgeries.It is alleged that the patient has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.It is alleged that the implantation and failure of the product has had a devastating impact on the patient, leaving the patient with permanent injuries including scarring, disfigurement, and chronic pain.It is alleged that the patient's adverse reaction, complications, and further surgery directly and proximately resulted from the defective and dangerous condition of the product.It is alleged that the injuries due to the implantation of the product have caused and continue to cause the patient experienced pain, suffering, permanent physical disability and the patient continues to undergo medical care and treatment.It is also alleged that the device was defective.

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• 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: 13695961
• Report Number: 1213643-2022-91590
• Device Sequence Number: 3906054
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: PREAMENDMENT
• 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): 03/08/2022

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: 06/28/2016
• Device Catalogue Number: 0113710
• Device Lot Number: HUVE1345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2011
• 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; Disability
• Patient Sex: Male