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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE; UNKNOWN WOUND DRAIN
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C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE; UNKNOWN WOUND DRAIN Back to Search Results
Device Problems Collapse (1099); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 facility had issues with the wound drains collapsing and clotting drains.No medical intervention was required.
 
Event Description
It was reported that facility had issues with the wound drains collapsing and clotting drains.No medical intervention was required.
 
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 wound drain product ifus are found to be adequate based on past reviews.
 
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Brand Name
WOUND DRAINAGE
Type of Device
UNKNOWN WOUND DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7925507
MDR Text Key122478013
Report Number1018233-2018-04515
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Date Manufacturer Received10/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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