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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 DEVICE
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C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKNOWN STATLOCK DEVICE Back to Search Results
Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Irritation (2076)
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 patient experienced skin irritation and peeling around the adhesive on the statlock which used in the hospital.Also stated that it pulled on the balloon and caused pain.Patient was now trying to use a foley hold leg bag strap but that caused irritation.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "design error(i.E.Improper fit of clamp/retainer to base)".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the statlock foley product ifus were found to be adequate based on past reviews.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 patient experienced skin irritation and peeling around the adhesive on the statlock which used in the hospital.Also stated that it pulled on the balloon and caused pain.Patient was now trying to use a foley hold leg bag strap but that caused irritation.No medical intervention was reported.
 
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Brand Name
STATLOCK SL FOLEY, UNKNOWN CODE
Type of Device
UNKNOWN STATLOCK DEVICE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10477807
MDR Text Key206306703
Report Number1018233-2020-05599
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,distributor,other
Type of Report Initial,Followup
Report Date 11/23/2020
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 08/10/2020
Initial Date FDA Received09/01/2020
Supplement Dates Manufacturer Received11/03/2020
Supplement Dates FDA Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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