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

Catalog Number	5959360
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Deformity/ Disfigurement (2360); Disability (2371)
Date of Event	07/18/2019
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, hernia recurrence and surgical intervention.The instructions-for-use supplied with the device lists 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 bard/davol sepramesh ip (device #2).An additional emdr was submitted to represent the bard/davol ventralex st (device #1).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 bard/davol ventralex st hernia patch and bard/davol sepramesh ip mesh to repair a hernia on (b)(6) 2014.It is alleged that the patient experienced severe pain and suffering, necessitating a mesh removal and revision surgery on (b)(6) 2019.The patient suffered severe complications following surgeries including abdominal pain, gastrointestinal malfunction, grotesque swelling, and hernia recurrence.The patient had permanent injuries and impairments, including scarring, disfigurement, chronic pain, and such further and other injuries.It is alleged that the patient experienced permanent physical disability, loss of physical, mental and emotional health, sustained certain special damages and had medical treatment.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: 10419499
• Report Number: 1213643-2020-07568
• Device Sequence Number: 14152024
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809
• 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
• Device Explanted Year: 2019
• 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: 07/28/2015
• Device Catalogue Number: 5959360
• Device Lot Number: HUXG1220
• 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: Required Intervention; Disability
• Patient Age: 76 YR