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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. DULEX SURGICAL MESH Back to Search Results
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. ".
 
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Brand NameDULEX
Type of DeviceSURGICAL 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 Key9415829
MDR Text Key169225033
Report Number1213643-2019-11736
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003917
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
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 Received12/05/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNKAA022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
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 Treatment Data
Date Received: 12/05/2019 Patient Sequence Number: 1
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