FDA Adverse Event
Malfunction
Summary report: N
CYCLESURE BIOLOGICAL INDICATOR
MDR report key: 1063780
·
Received June 19, 2008
Report
- Report Number
- 2084725-2008-00291
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 19, 2008
- Report Date
- May 21, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- FRC
- PMA / PMN Number
- K994055
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OTHER, SUSPECTED POSITIVE BI.
Description of Event or Problem · 1
THE AFFILIATE REPORTED THAT A CUSTOMER WHO STATED THAT A CYCLESURE BIOLOGICAL INDICATOR (BI) RESULTED POSITIVE. THE CUSTOMER DID NOT RECALL ALL ITEMS FROM THE LOAD. THE CUSTOMER DID NOT PROVIDE ANY INFO REGARDING POTENTIAL PT INJURY RELATED TO THE UNRECALLED ITEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYCLESURE BIOLOGICAL INDICATOR | BIOLOGICAL INDICATOR | FRC | ADVANCED STERILIZATION PRODUCTS | NA | 05171Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |