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

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.

• Brand Name: CAP ANTI-EMBOLISM STOCKINGS
• Type of Device: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
• Manufacturer (Section D): CAROLON CO.; 601 forum parkway; rural hall NC 27045
• MDR Report Key: 6338689
• MDR Text Key: 67677034
• Report Number: 6338689
• Device Sequence Number: 1
• Product Code: DWL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 288 16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NONE KNOWN