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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Deformity/ Disfigurement (2360); Disability (2371)
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 permanent injury and hernia recurrence.The instructions-for-use supplied with the device lists recurrence as a possible complication.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 on (b)(6) 2012, the patient was implanted with two non-bard/davol mesh products to repair a hernia.The non-bard/davol mesh failed, causing the patient to experience severe pain and suffering, and necessitating a partial mesh removal and revision surgery on (b)(6) 2018.A bard/davol product namely sepramesh ip was used in the repair.The defective mesh devices has caused the patient to experience severe pain and suffering and left the patient living with chronic pain.The patient suffered severe complications following surgeries including abdominal pain, gastrointestinal malfunction, grotesque swelling and hernia recurrence.Due to the implantations and failures of the defective mesh devices, the patient experienced permanent injuries and impairments, including scarring, disfigurement, chronic pain, and other further injuries.The injuries due to implantation of defective mesh devices has caused and continue to cause the patient pain, suffering, permanent physical disability and loss of physical, mental and emotional health.The patient continues to undergo medical care and treatment and alleges for further medical care in foreseeable future.It is also alleged that the device was defective.

• 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
• MDR Report Key: 10421258
• Report Number: 1213643-2020-07569
• Device Sequence Number: 2816306
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: 08/28/2018
• Device Catalogue Number: 5959812
• Device Lot Number: HUAV0129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 44 YR