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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN AVAULTA - BARD; UNKNOWN AVAULTA SUPPORT SYSTEM
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN AVAULTA - BARD; UNKNOWN AVAULTA SUPPORT SYSTEM Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Discharge (2225); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.
 
Event Description
It was reported that in 2011 the patient allegedly experienced pain, bleeding, and discharge.The patient had a vaginal mesh inserted in 2010 and was found to have a large posterior vaginal mesh extrusion, which required surgery to remove the mesh.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the unknown avaulta - bard product ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that in 2011 the patient allegedly experienced pain, bleeding, and discharge.The patient had a vaginal mesh inserted in 2010 and was found to have a large posterior vaginal mesh extrusion, which required surgery to remove the mesh.
 
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Brand Name
UNKNOWN AVAULTA - BARD
Type of Device
UNKNOWN AVAULTA SUPPORT SYSTEM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7794753
MDR Text Key117567451
Report Number1018233-2018-03639
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K083840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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