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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY
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C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY Back to Search Results
Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
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 the statlock had strong adhesive and was therefore difficult to remove.It was reported that the patient must use alcohol in order to remove the statlock device.
 
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 statlock sl foley ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that the statlock had strong adhesive and was therefore difficult to remove.It was reported that the patient must use alcohol in order to remove the statlock device.
 
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Brand Name
STATLOCK SL FOLEY
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7512293
MDR Text Key108370386
Report Number1018233-2018-01709
Device Sequence Number1
Product Code EYJ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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