FDA Adverse Event
Malfunction
Summary report: N
RUSCH RI FIBER-OPTIC LARYNGOSCOPE KIT
MDR report key: 4188203
·
Received October 16, 2014
Report
- Report Number
- 1044475-2014-00285
- Event Type
- Malfunction
- Date Received
- October 16, 2014
- Date of Event
- September 26, 2014
- Report Date
- September 29, 2014
- Manufacturer
- TELEFLEX
- Product Code
- OGH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.
Description of Event or Problem · 1
THE COMPLAINT ALLEGES THAT THE HANDLE STOPPED WORKING. THERE WERE NO REPORTS OF PATIENTS HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656617 | RUSCH RI FIBER-OPTIC LARYNGOSCOPE KIT | MRI LARYNGOSCOPE KIT | OGH | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |