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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROLON CO. CAP ANTI-EMBOLISM STOCKINGS STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

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CAROLON CO. CAP ANTI-EMBOLISM STOCKINGS STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) Back to Search Results
Lot Number 288 16
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2017
Event Type  Malfunction  
Event Description

The rn obtained support stockings from the supply room. When in the room while opening the package the nurse noticed the stockings were moldy. The nurse returned to the supply room and noted all of the stockings in the same condition. The materials checked the lot number and removed all items with this lot number. Unfortunately, materials discarded the items instead of returning to the manufacturer.

 
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Brand NameCAP ANTI-EMBOLISM STOCKINGS
Type of DeviceSTOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
Manufacturer (Section D)
CAROLON CO.
601 forum parkway
rural hall NC 27045
MDR Report Key6338689
MDR Text Key67677034
Report Number6338689
Device Sequence Number1
Product Code DWL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2017
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT Number288 16
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/09/2017
Event Location Hospital
Date Report TO Manufacturer02/09/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/17/2017 Patient Sequence Number: 1
Treatment
NONE KNOWN
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