MAUDE Adverse Event Report: SEPRAMESH IP; SURGICAL MESH

Catalog Number	5959480
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)
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, bowel obstruction, chronic pain and subsequent surgical intervention.The instructions-for-use (ifu) supplied with the device lists hernia recurrence and inflammation as possible complications.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).Additional emdrs were submitted to represent the bard/davol sepramesh ip (device #1) and bard/davol ventralex mesh (device #3).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient was implanted with a bard/davol sepramesh ip.It is alleged that on(b)(6) 2011, the patient was implanted with the product in the course of an incisional hernia repair surgery.It is alleged that further to the patient's implantation with the product, the patient suffered the development of chronic pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence, necessitating further reparative surgery which occurred on 17-aug-2011 where a bard/davol sepramesh ip was implanted.It is alleged that subsequent to the surgery, the patient has continued to suffer from chronic pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence which resulted in the patient requiring various additional 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 patient experienced severe pain and suffering, including chronic pain.The patient has been treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation, and will continue to require other medical care.Attorney also alleged that the device was defective.Note: the patient was also implanted with a ventralex hernia patch and claim of adverse patient outcome has been made against the device.

• Brand Name: SEPRAMESH IP
• Common Device Name: SURGICAL MESH
• MDR Report Key: 12741178
• Report Number: 1213643-2021-08416
• Device Sequence Number: 4127067
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816
• 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): 11/02/2021

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: 06/28/2013
• Device Catalogue Number: 5959480
• Device Lot Number: HUVF0988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2011
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 40 YR