FDA Adverse Event
Other
Summary report: N
METRICIDE OPA PLUS
MDR report key: 2648437
·
Received June 28, 2012
Report
- Report Number
- 1221361-2012-00001
- Event Type
- Other
- Date Received
- June 28, 2012
- Report Date
- June 24, 2012
- Manufacturer
- ALDEN MEDICAL LLC
- Product Code
- MED
- PMA / PMN Number
- K070627
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INCOMPLETE DESCRIPTION OF THE EVENT WAS PROVIDED BY THE USER FACILITY TO THE DISTRIBUTOR. THE DISTRIBUTOR FORWARDED THIS DESCRIPTION TO THE MANUFACTURER. THE MANUFACTURER AND THE DISTRIBUTOR BOTH ATTEMPTED TO CLARIFY THE CORRELATION BETWEEN THE EVENT AND THE USE OF THE PRODUCT. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY IN ORDER TO OBTAIN MORE INFORMATION. HOWEVER, ALL ATTEMPTED REQUESTS FOR INFORMATION WERE IGNORED BY THE USER FACILITY. NO DETAILS ARE KNOWN ON WHAT ROLE, IF ANY, THE PRODUCT MAY HAVE PLAYED IN THE EVENT.
Description of Event or Problem · 1
A USER FACILITY WHICH USES THIS PRODUCT TO DISINFECT MEDICAL DEVICES INDICATED PATIENT REACTIONS MAY HAVE OCCURRED AFTER USING THIS PRODUCT ON EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | METRICIDE OPA PLUS | HIGH LEVEL DISINFECTANT | MED | ALDEN MEDICAL LLC | NA | 1811541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |