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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, UNKNOWN CODE; UNKNOWN STATLOCK
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C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKNOWN STATLOCK Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problem Skin Discoloration (2074)
Event Date 12/31/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the patient experienced the difficulty in using the adhesive pad which was used to secure the foley catheter to the leg.Also stated, that the instruction was given to saturate with alcohol during the removal.It was noted that the pad would not come off easily and the skin would not tear.
 
Manufacturer Narrative
The reported event could not be confirmed.Visual inspection noted two photo samples were received.Visual evaluation noted both photos show an imprint of where the foley statlock was placed on the skin.The pad markings can be seen on the skin, most likely due to the use of alcohol on the pad to transfer the dye to the skin.It was unknown the strength of the adhesive due to the photos and therefore the results of the investigation were inconclusive.A potential root cause for this failure could be adhesive chemistry not appropriate for application (too aggressive).The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog and lot number for this device was unknown.Therefore, bard was unable to determine the associated labeling to review.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.
 
Event Description
It was reported that the patient experienced the difficulty in using the adhesive pad which was used to secure the foley catheter to the leg.Also stated, that the instruction was given to saturate with alcohol during the removal.It was noted that the pad would not come off easily and the skin would not tear.
 
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Brand Name
STATLOCK SL FOLEY, UNKNOWN CODE
Type of Device
UNKNOWN STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11214557
MDR Text Key228215885
Report Number1018233-2021-00065
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 health professional,other
Type of Report Initial,Followup
Report Date 05/26/2021
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 Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2020
Initial Date Manufacturer Received 12/31/2020
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received05/26/2021
Supplement Dates FDA Received06/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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