FDA Adverse Event
Injury
Summary report: N
STOP GRINDING
MDR report key: 4113718
·
Received May 1, 2014
Report
- Report Number
- 1825660-2014-00822
- Event Type
- Injury
- Date Received
- May 1, 2014
- Date of Event
- April 8, 2014
- Report Date
- May 1, 2014
- Manufacturer
- RANIR, LLC
- Product Code
- OBR
- PMA / PMN Number
- K091175
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO ADD'L INFO IS GIVEN BY THE CONSUMER. NO LOT CODE WAS GIVEN, NO PRODUCT WAS RETURNED FOR INVESTIGATION. NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS SOUGH. THIS IS BEING REPORTED BECAUSE IF THE DEVICE IS SWALLOWED, MEDICAL ATTENTION MAY BE NECESSARY TO REMOVE THE DEVICE.
Description of Event or Problem · 1
SHE PURCHASED THE PRODUCT. "WHAT A FARCE AND WASTE OF MONEY". IT WILL NOT STAY ON THE TEETH AND IT CAME OFF DURING THE NIGHT AND SHE NEARLY SWALLOWED IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262410 | STOP GRINDING | BRUXISM DEVICE | OBR | RANIR, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |