FDA Adverse Event
Summary report: N
DENT SLEEVE - PVB TRANSDUCER
MDR report key: 2445039
·
Received January 25, 2012
Report
- Report Number
- 2445039
- Date Received
- January 25, 2012
- Report Date
- January 17, 2012
- Manufacturer
- MUI SCENTIFIC
- Product Code
- DRS
- Report Source
- User Facility report
- Reporter Location
- LA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PACKAGE IS LABELED AS A SINGLE USE, BUT THE MANUFACTURER INSTRUCTIONS INDICATE USE OF HIGH LEVEL DISINFECTANT FOR MULTIPLE USE OF THIS PRODUCT. WHEN THE MANUFACTURER WAS CALLED IN (B)(4), THEY REPORTED TO GO WITH THE MANUAL. THE PACKAGE AND THE MANUAL ARE VERY CONFUSING, ONE SAYS ONE WAY AND THE OTHER ANOTHER WAY.======================MANUFACTURER RESPONSE FOR PRESSURE TRANSDUCER, DENT SLEEVE - PVB TRANSDUCER (PER SITE REPORTER).======================MANUFACTURER WAS SPOKEN WITH AND THERE SEEMS TO BE A COMMUNICATION BARRIER. THEY SUGGEST TO FOLLOW THE MANUFACTURER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DENT SLEEVE - PVB TRANSDUCER | PRESSURE TRANSDUCER | DRS | MUI SCENTIFIC | DPT-6000 | 917726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NO OTHER THERAPIES |