FDA Adverse Event
Summary report: N
TUTTNAUER
MDR report key: 22411
·
Received February 23, 1995
Report
- Report Number
- 2435367-1995-00001
- Date Received
- February 23, 1995
- Date of Event
- July 15, 1994
- Report Date
- February 9, 1995
- Manufacturer
- TUTTNAUER CO., LTD.
- Product Code
- FLE
- Report Source
- Distributor report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DOOR LATCH ON A TUTTNAUER AUTOCLAVE MALFUNCTIONED. CAUSING THE DOOR TO OPEN SUDDENLY 1/8". THE AUTOCLAVE BELONNGED TO THE HUNTER DENTAL CLINIC. NO PTS WERE INJURED, BUT AN ATTORNEY HAS CONTACTED US ALLEGING THAT HIS CLIENT, A DENTAL TECHNICIAN AT THE CLINIC MAY HAVE SUFFERED AN INJURY OF AN UED TYPE WHEN THE AUTOCLAVE MALFUNCTIONED. THE MALFUNCTION WAS CAUSED BY A BALLBEARING THAT BROKE DUE TO OVERTIGHTENING OF THE BOLT BY THE USER. THE AUTOCLAAVE DOOR HAS A SAFETY LATCH THAT PREVENTS THE DOOR FROM OPENING MORE THAN 1/8". THE SAFETY LATCH FUNCTIONED PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUTTNAUER | AUTOCLAVE | FLE | TUTTNAUER CO., LTD. | MK 2540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |