FDA Adverse Event
Malfunction
Summary report: N
MEDIVATORS
MDR report key: 1923384
·
Received December 13, 2010
Report
- Report Number
- 2150060-2010-00156
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- November 19, 2010
- Report Date
- December 13, 2010
- Manufacturer
- MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH
- Product Code
- FEB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE NURSE WAS TREATED AND RELEASED, NO STITCHES REQUIRED. (B)(4), UNEXPECTED BREAKAGE.
Description of Event or Problem · 1
THE GLASS LID FROM THE AER BROKE, THE NURSE RECEIVED A MINOR LACERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDIVATORS | ENDOSCOPE DISINFECTOR | FEB | MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH | 1-2-430.003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |