FDA Adverse Event
Malfunction
Summary report: N
CYCLESURE BIOLOGICAL INDICATOR
MDR report key: 931517
·
Received April 6, 2007
Report
- Report Number
- 2084725-2007-00094
- Event Type
- Malfunction
- Date Received
- April 6, 2007
- Date of Event
- April 3, 2007
- Report Date
- April 3, 2007
- Manufacturer
- AVAIL MEDICAL PRODUCTS
- Product Code
- FRC
- PMA / PMN Number
- K994055
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A HEALTHCARE WORKER COMPLAINED OF BURNING SENSATION AND SKIN DISCOLORATION ON THE HAND UPON HANDLING A BI PACKAGE FROM A COMPLETED CYCLE. THE WORKER DID NOT RECEIVE MEDICAL TREATMENT AND THE SYMPTOMS RESOLVED WITHIN A FEW HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYCLESURE BIOLOGICAL INDICATOR | INDICATOR, BIOLOGICAL | FRC | AVAIL MEDICAL PRODUCTS | 14324 | 04071Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | STERRAD 100S STERILIZATION SYSTEM, MODEL # 10101 |