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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 SILICONE TRICOT 25BX STATLOCK

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C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX STATLOCK Back to Search Results
Catalog Number FOL0102
Device Problems Product Quality Problem (1506); Difficult to Remove (1528)
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 device was not returned.
 
Event Description
It was reported that the statlock was extremely sticky and hard to remove from the skin.
 
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Brand NameSL FOLEY SWIVEL SILICONE TRICOT 25BX
Type of DeviceSTATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9964846
MDR Text Key188201900
Report Number1018233-2020-02611
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741076114
UDI-Public(01)00801741076114
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2022
Device Catalogue NumberFOL0102
Device Lot NumberJUDTF577
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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