FDA Adverse Event
Injury
Summary report: N
METRICIDE OPA PLUS
MDR report key: 1982705
·
Received February 4, 2011
Report
- Report Number
- 1221361-2011-00001
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 3, 2011
- Manufacturer
- ALDEN MEDICAL LLC
- Product Code
- MED
- PMA / PMN Number
- K070627
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
END USER FACILITY USED DISINFECTANT (METRICIDE OPA PLUS) TO DISINFECT A BRONCHOSCOPE. FOLLOWING DISINFECTION, THE BRONCHOSCOPE REQUIRES A RINSING PROCESS TO REMOVE THE DISINFECTANT FROM ITS SURFACES PRIOR TO ITS USE ON A PATIENT. THE END USER HALTED THE RINSING PROCESS APPROXIMATELY 6 MINUTES BEFORE REACHING ITS COMPLETION, AND THE BRONCHOSCOPE WAS THEN USED ON A PATIENT. FOLLOWING USE, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | METRICIDE OPA PLUS | MED | ALDEN MEDICAL LLC | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization |