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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number UNKAA030
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Death (1802); Injury (2348); Disability (2371)
Event Date 04/06/2020
Event Type  Death  
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 death and permanent injury. No medical records, autopsy report, or death certificate have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard flat mesh (device #1). An additional emdr was submitted to represent the bard flat mesh (device #2). 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 two unspecified bard mesh (bard flat mesh) on (b)(6) 2003 and (b)(6) 2006. As reported, the patient is making a claim for an adverse patient outcome against both devices. Attorney alleges wrongful death of the patient. It is alleged that the patient passed away on (b)(6) 2020 due to the defendants¿ negligence, defective product, defective design, failure to warn, and/or other wrongful act(s). 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. " it is also alleged that the patient experienced emotional distress and the device was defective.
 
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Brand NameBARD FLAT MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED 3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10670421
MDR Text Key211030537
Report Number1213643-2020-09337
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
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: 10/13/2020 Patient Sequence Number: 1
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