FDA Adverse Event
Malfunction
Summary report: N
P.A.S. STOCKINGS
MDR report key: 43898
·
Received October 21, 1996
Report
- Report Number
- MW1010107
- Event Type
- Malfunction
- Date Received
- October 21, 1996
- Date of Event
- October 8, 1996
- Report Date
- October 10, 1996
- Manufacturer
- ALBA-WALDENSIAN, INC.
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STOCKINGS WERE REMOVED AFTER NOTING 2 INDENTATIONS ON PT'S ANKLES. ALSO NOTED SEVERE INDENTATIONS BELOW KNEES. STOCKINGS WERE ON PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | P.A.S. STOCKINGS | PULSATILE ANTI-EMBOLISM STOCKINGS | JOW | ALBA-WALDENSIAN, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |