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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL 25BX; STATLOCK
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C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL 25BX; STATLOCK Back to Search Results
Catalog Number FOL0101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Tears (2516)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that patient was having issue with statlock causing skin tear.
 
Manufacturer Narrative
Per clinical review, it has been determined that this event is not reportable and has been downgraded.H11:section a through f - 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.H3 other text : the device was not returned.
 
Event Description
It was reported that the patient was having issues with the statlock causing a skin tear.
 
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Brand Name
SL FOLEY SWIVEL 25BX
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10038222
MDR Text Key190752478
Report Number1018233-2020-03090
Device Sequence Number1
Product Code EYJ
UDI-Device Identifier00801741076091
UDI-Public(01)00801741076091
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberFOL0101
Was Device Available for Evaluation? No
Date Manufacturer Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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