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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN STATLOCK SL FOLEY
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN STATLOCK SL FOLEY Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem 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 "back piece" of the statlock comes off, and the "statlock comes apart after less than 24 hours" of use.
 
Event Description
It was reported that the "back piece" of the statlock comes off, and the "statlock comes apart after less than 24 hours" of use.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the statlock sl foley product ifus are found to be adequate based on past reviews.Device code: (b)(4).Patient code: (b)(4).
 
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Brand Name
UNKNOWN STATLOCK SL FOLEY
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7343198
MDR Text Key102752599
Report Number1018233-2018-00818
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 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 02/23/2018
Initial Date FDA Received03/15/2018
Supplement Dates Manufacturer Received03/26/2018
Supplement Dates FDA Received03/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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