FDA Adverse Event
Malfunction
Summary report: N
CYCLESURE BIOLOGICAL INDICATOR
MDR report key: 1140673
·
Received August 28, 2008
Report
- Report Number
- 2084725-2008-00547
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 7, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- FRC
- PMA / PMN Number
- K031226
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE AFFILIATE REPORTED A CUSTOMER WHO REPORTED THAT AN INDICATOR USED AS A CONTROL, WHICH WAS SUPPOSED TO BE POSITIVE, WAS NEGATIVE. THE AFFILIATE COULD NOT REPORT WHETHER OR NOT THE LOAD WAS RECALLED AND IF THERE WERE ANY REPORTS OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYCLESURE BIOLOGICAL INDICATOR | INDICATOR, BIOLOGICAL | FRC | ADVANCED STERILIZATION PRODUCTS | NA | 36071Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |