FDA Adverse Event
Summary report: N
ACTIVECARE
MDR report key: 2282298
·
Received September 30, 2011
Report
- Report Number
- 2282298
- Date Received
- September 30, 2011
- Date of Event
- May 22, 2011
- Report Date
- September 28, 2011
- Manufacturer
- MEDICAL COMPRESSION SYSTEMS LTD.
- Product Code
- JOW
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
SEQUENTIAL COMPRESSION STOCKINGS CAUSED BILATERAL ACHILLES TENDON PRESSURE ULCERS: BLISTERING/STAGE II. COTTON STOCKINETTS WERE NOT USED DUE TO MOISTURE PRODUCTION AND BUNCHING UP WHEN USED UNDER THE CALF SLEEVE. ======================MANUFACTURER RESPONSE FOR SEQUENTIAL COMPRESSION DEVICE, ACTIVE CARE (PER SITE REPORTER).======================THERE WERE COMORBITIES THAT PRE-DISPOSITIONED THE PATIENT FOR PRESSURE ULCER. MAY HAVE BEEN USER ISSUE IE: FREQUENCY OF SKIN CHECKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVECARE | SEQUENTIAL COMPRESSION DEVICE | JOW | MEDICAL COMPRESSION SYSTEMS LTD. | DVT | 1112301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | CARDIAC DRUGS| LONG-TERM ANTIBIOTICS |