FDA Adverse Event
Malfunction
Summary report: N
RUSCH MIR COND FIBER OPTIC LARYN KIT
MDR report key: 4460512
·
Received January 26, 2015
Report
- Report Number
- 1044475-2015-00037
- Event Type
- Malfunction
- Date Received
- January 26, 2015
- Date of Event
- January 8, 2014
- Report Date
- January 9, 2014
- Product Code
- OGH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE CUSTOMER ALLEGES THAT THE MILLER 2 BLADE IS NO LONGER MAKING A CONNECTION TO LIGHT UP THE PIPE. NO PT INJURY OR CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59135 | RUSCH MIR COND FIBER OPTIC LARYN KIT | LARYNGOSCOPE KIT | OGH | 131401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |