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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

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C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM Back to Search Results
Catalog Number 486010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Burning Sensation (2146); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
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
The patient¿s attorney alleged a deficiency against the device. Per additional information received, the patient has experienced vulvar burning and itching, urinary leakage, pessary use, grade two cystocele, vulvar yeast, urge incontinence, questionable retention, not emptying well, pad use, vulvitis, urinary frequency, urinary urgency, vulvar abscess and vaginal prolapse and required multiple surgical and nonsurgical interventions.
 
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Brand NameAVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
Type of DeviceAVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9086350
MDR Text Key162084815
Report Number1018233-2019-05772
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/19/2019,01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number486010
Device Lot NumberZGJ00188
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2019
Distributor Facility Aware Date12/11/2020
Event Location Hospital
Date Report to Manufacturer09/19/2019
Date Manufacturer Received12/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/19/2019 Patient Sequence Number: 1
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