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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
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C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM Back to Search Results
Catalog Number 486020
Device Problem Defective Device (2588)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.
 
Manufacturer Narrative
Correction: f2: per email received from the fda on 11dec2020, a correction is being submitted for f2 as the initial mdr report inadvertently included the manufacture report no h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
Na.
 
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Brand Name
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
Type of Device
AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9209395
MDR Text Key162985776
Report Number1018233-2019-06604
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/18/2019,01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number486020
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2019
Distributor Facility Aware Date12/11/2020
Event Location Hospital
Date Report to Manufacturer10/18/2019
Date Manufacturer Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM.; PELVILACE TO BIOURETHRAL SUPPORT SYSTEM.
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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