FDA Adverse Event
Summary report: N
ALP
MDR report key: 2053645
·
Received April 5, 2011
Report
- Report Number
- 2053645
- Date Received
- April 5, 2011
- Date of Event
- February 11, 2011
- Report Date
- April 5, 2011
- Manufacturer
- HEALTHCARE SERVICE AND SUPPLY
- Product Code
- JOW
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
PATIENT WAS UNDERGOING OUTPATIENT (TYMPANOPLASTY) PROCEDURE. THE COMPRESSION UNIT HAD BEEN APPLIED. UPON AWAKENING, THE PATIENT COMPLAINED OF SEVERE RIGHT LEG PAIN. AN X-RAY OF THE RIGHT LOWER EXTREMITY WAS NORMAL. FURTHER EVALUATION OF THE EXTREMITY DID REVEAL SOME SWELLING. THE PATIENT WAS ADMITTED FOR OBSERVATION AND PROGRESSION OF SWELLING RESULTED IN THE NEED FOR A RETURN TO SURGERY FOR A FASCIOTOMY OF THE RIGHT LOWER EXTREMITY. THE PATIENT WAS DISCHARGED ON POST OP DAY THREE AND DID REQUIRE OUTPATIENT PHYSICAL THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALP | COMPRESSION UNIT | JOW | HEALTHCARE SERVICE AND SUPPLY | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |