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

Catalog Number UNKAA022

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

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

Event Date 04/28/2019

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges injuries; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.No medical records, autopsy, or death certificate have been provided.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 dulex eptfe on (b)(6) 2006.It is also alleged by patient attorney that on (b)(6) 2019 and (b)(6) 2019, the patient had unspecified injuries.It is also alleged, by the patient's attorney that on (b)(6) 2019, patient passed away.As alleged, this short form complaint asserts a claim for wrongful death by the personal representative for the estate of the patient.As reported, the patient is making a claim for an adverse patient outcome against the dulex eptfe.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.".

• Brand Name: DULEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BRIDGER BIOMED, INC. -3031159; 2430 north 7th avenue; bozeman MT 59715
• Manufacturer Contact: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 9415829
• MDR Text Key: 169225033
• Report Number: 1213643-2019-11736
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Disability