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

Catalog Number	5959680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
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, adhesions and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists recurrence, adhesions, and inflammation as possible complications.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.
Event or Problem Description
Attorney alleges that the patient underwent an incisional hernia repair surgery for implant of a bard/davol sepramesh ip on (b)(6) 2011.It is alleged that further to the implantation of the product, the patient suffered the development of chronic pain, inflammation, adhesions and hernia recurrences necessitating subsequent revision surgery and the removal of the product.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.Attorney alleges that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.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: 12322192
• Report Number: 1213643-2021-06872
• Device Sequence Number: 11837579
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2021

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: 02/28/2013
• Device Catalogue Number: 5959680
• Device Lot Number: HUVB1354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/14/2021
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR