FDA Adverse Event
Other
Summary report: N
MILTEX
MDR report key: 101214
·
Received June 25, 1997
Report
- Report Number
- 2431021-1997-00003
- Event Type
- Other
- Date Received
- June 25, 1997
- Date of Event
- June 2, 1997
- Report Date
- June 23, 1997
- Manufacturer
- MILTEX INSTRUMENT CO. INC
- Product Code
- EAX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 6/02/97 DURING DENTAL TREATMENT THE MIRROR HEAD DISCONNECTED AT THE SOLDER (SPOTWELD) JOINT AND WAS SWALLOWED BY THE PT. FOLLOW UP NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILTEX | DENTAL MIRROR | EAX | MILTEX INSTRUMENT CO. INC | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |