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

Catalog Number UNKAA066

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Death (1802); Pain (1994); Injury (2348); Disability (2371)

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol sepramesh composite ip on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh composite ip.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".

Manufacturer Narrative

At this time no conclusions can be made.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: this is an addendum to the initial emdr submitted on 22-aug-2019.A new legal claim from a second attorney for the patient has alleged wrongful death of the patient and subsequent surgical intervention.Therefore, a supplemental emdr was submitted.Should additional information be provided a supplemental emdr will be submitted.

Event Description

Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol sepramesh composite ip on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh composite ip.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum as per legal claim: attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol sepramesh ip on (b)(6) 2017.As reported, the plaintiff is making a claim for an adverse patient outcome against the sepramesh ip.Attorney alleges that the patient had wrongful death and subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.

• Brand Name: SEPRAMESH IP
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8920784
• MDR Text Key: 155204399
• Report Number: 1213643-2019-07402
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Disability