FDA Adverse Event
Malfunction
Summary report: N
STORZ LEIVERS MOUTH GAG FRAM-CHILD SIZE RIGHT
MDR report key: 43007
·
Received October 17, 1996
Report
- Report Number
- 1932180-1996-00090
- Event Type
- Malfunction
- Date Received
- October 17, 1996
- Date of Event
- September 17, 1996
- Report Date
- September 17, 1996
- Manufacturer
- STORZ INSTRUMENT COMPANY
- Product Code
- KBN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE THUMB LEVER ON THE MOUTH GAG WAS FOUND TO BE BROKEN WHEN THE PHYSICIAN ATTEMPTED TO INSERT IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STORZ LEIVERS MOUTH GAG FRAM-CHILD SIZE RIGHT | MOUTH GAG | KBN | STORZ INSTRUMENT COMPANY | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |