FDA Adverse Event
Malfunction
Summary report: N
CYCLESURE BIOLOGICAL INDICATOR
MDR report key: 905865
·
Received March 14, 2007
Report
- Report Number
- 2084725-2007-00074
- Event Type
- Malfunction
- Date Received
- March 14, 2007
- Date of Event
- February 26, 2007
- Report Date
- February 27, 2007
- Manufacturer
- AVAIL MEDICAL PRODUCTS
- Product Code
- FRC
- PMA / PMN Number
- k031226
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A HEALTHCARE WORKER COMPLAINED OF SKIN DISCOLORATION ON THE HANDS UPON HANDLING A BI POUCH WHERE THE CYCLESURE BIOLOGICAL INDICATOR VIAL LEAKED. THESE ITEMS WERE PROCESSED IN THE STERRAD 100S. THE WORKER WASHED THE CONTACT AREA WITH WATER AND DID NOT RECEIVE MEDICAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYCLESURE BIOLOGICAL INDICATOR | INDICATOR, BIOLOGICAL | FRC | AVAIL MEDICAL PRODUCTS | 14324 | 26561Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | STERRAD 100S STERILIZATION SYSTEM, MODEL # 10101 |