FDA Adverse Event Injury Summary report: N

CAP

MDR report key: 10561 · Received December 20, 1993

Report

Report Number
MW1000138
Event Type
Injury
Date Received
December 20, 1993
Date of Event
September 11, 1993
Report Date
December 8, 1993
Manufacturer
CAROLON CO.
Product Code
DWL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

RPTR HAD KNEE HIGH ANTI-EMBOLISM STOCKINGS APPLIED THE MORNING OF 9/11/93 WHILE SHE WAS STILL LYING DOWN. WITHIN A 4 HOUR PERIOD, AFTER SITTING IN HER WHEELCHAIR WITH FEET SUPPORTED ON FOOTRESTS, THERE WAS A GREAT INCREASE IN BILATERAL ANKLE EDEMA FROM THIS PT'S NORMAL BASELINE LEVEL. THE STOCKINGS WERE REMOVED AT THAT TIME. INDURATIONS ON THE EDEMATIOUS TISSUE WERE NOTED WHERE THE STOCKING WEAVE CHANGES AT THE ANKLE. IT APPEARS THE CHANGE IN THE WEAVE AT THAT SPOT IS RESPONSIBLE FOR POOLING EXTRA FLUID BELOW THAT SITE. RPTR DID NOT COMPLAIN OF PAIN, HER FEET WERE COLD TO THE TOUCH WITHOUT DISCOLORATION. THIS BRAND OF STOCKING WAS TRIED ON OTHER PTS (BOTH AT THE SAME FACILITY AND A DIFFERENT FACILITY). ALL OTHER PTS COMPLAINED OF INCREASE IN ANKLE EDEMA FROM BASELINE. THEY ALSO COMPLAINED OF A LOT OF PAIN AT THE SITE. THE STOCKINGS WERE REMOVED AND INDURATION MARKS WERE NOTED BY NURSING STAFF AT THE ANKLE WHERE THE WEAVE IN THE STOCKING CHANGES. IN EACH INCIDENT ABOVE, THE STOCKINGS WERE LEFT OFF AND THE PT'S LOWER EXTREMETIES WERE ELEVATED TO RELIEVE DISCOMFORT AND REDUCE THE EDEMA. THIS BRAND OF STOCKING WAS LATER REPLACED WITH A DIFFERENT BRAND AND NO FURTHER PROBLEMS AS LISTED ABOVE DEVELOPED. OBVIOUSLY THERE IS A PROBLEM WITH THE DESIGN OF THIS ANTI-EMBOLISM STOCKING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CAP ANTI-EMBOLISM STOCKINGS; THIGH AND CALF LENGTH DWL CAROLON CO.

Patients

Seq Age Sex Outcome Treatment
1 88 YR Required Intervention