FDA Adverse Event
Malfunction
Summary report: N
CIDEX OPA CONCENTRATE
MDR report key: 1071697
·
Received July 9, 2008
Report
- Report Number
- 2084725-2008-00363
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 14, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- LRJ
- PMA / PMN Number
- K032959
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE AFFILIATE REPORTED A CUSTOMER THAT EXPERIENCED CIDEX OPAC LEAKS FROM CRACKED ON THEIR ADAPTASCOPE MACHINE. THE CUSTOMER REPORTED THAT THEY APPLIED SEALING GLUE, HOWEVER, THE LEAKS STILL OCCURRED. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS RELATED TO THE MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIDEX OPA CONCENTRATE | STERILANT, MEDICAL DEVICE | LRJ | ADVANCED STERILIZATION PRODUCTS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | ADAPTASCOPE CATALOG #: UNKNOWN |