FDA Adverse Event
Other
Summary report: N
TOBII TECHNOLOGY AB
MDR report key: 3213423
·
Received June 3, 2013
Report
- Report Number
- 3005301283-2013-00001
- Event Type
- Other
- Date Received
- June 3, 2013
- Date of Event
- November 22, 2012
- Report Date
- February 29, 2012
- Manufacturer
- TOBII TECHNOLOGY AB
- Product Code
- MOQ
- Report Source
- Distributor report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUT OF AN ABUNDANCE OF CAUTION, WE ARE REPORTING THIS INCIDENT. NO ONE HAS BEEN INJURED. THIS IS THE FIRST KNOWN OCCURRENCE. WE WILL MONITOR AND RESEARCH FURTHER.
Description of Event or Problem · 1
(B)(6) 2011 CUSTOMER CALLED TOBII ATI TO COMPLAIN THAT THEIR "BATTERY ONLY LASTED 2 HOURS." A RETURN AUTHORIZATION (B)(4) WAS CREATED. (B)(6) 2012 BATTERY PACK WAS RECEIVED AT TOBII ATI. (B)(4), 2012 BATTERIES WERE EXAMINED AND DURING REPAIR WE FOUND THE INTERNAL BATTERIES APPEARED SWOLLEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245598 | TOBII TECHNOLOGY AB | BATTERY PACK FOR P10 | MOQ | TOBII TECHNOLOGY AB | 510410 | NONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |