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

Catalog Number	5959812
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient was implanted with a bard/davol sepramesh ip (cat #5959812 and lot #huwi1169).It is alleged that on (b)(6) 2014, the patient was implanted with the product in the course of a ventral hernia repair surgery.It is alleged that further to the implantation with the product, the patient suffered the development of hernia recurrence, scar tissue, infection, fistula, bowel obstruction and chronic pain.It is alleged that on (b)(6) 2017, the patient underwent a corrective revision surgery.The patient underwent another corrective revision surgery on (b)(6) 2018.Attorney alleges 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 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 injuries due to the implantation of the product have caused and continue to cause the patient's pain, suffering, loss of enjoyment of life, permanent physical disability, loss of physical, mental and emotional health.It is also alleged that the patient continues to undergo medical care and treatment.It is also alleged 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 permanent injury, hernia recurrence, bowel obstruction, infection, fistula and subsequent surgical intervention.The instructions-for-use (ifu) supplied with the device lists hernia recurrence and fistula formation as possible complications.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." 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.

• Brand Name: SEPRAMESH IP
• 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: 13358101
• Report Number: 1213643-2022-90415
• Device Sequence Number: 11923893
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 09/28/2014
• Device Catalogue Number: 5959812
• Device Lot Number: HUWI1169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• 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 Sex: Male