MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-10 for DENTEK MAXIUMUM PROTECTION DENTAL GUARD manufactured by Prestige Brands Inc..
[132624757]
On (b)(6) 2018, a male consumer used a dentek maximum protection dental guard for an unknown indication and experienced stomach pains after accidentally swallowing the device. The consumer did not provide his age, medical history, concomitant medications or allergies. The duration and frequency of use of the mouthguard were not reported. The consumer stated he had issues fitting the device and it was loose in his mouth. He went to the emergency room for the abdominal pains and was advised that he "should pass the device or it would cause a blockage". The case outcome was not resolved at the time of contact with consumer, and he was advised to contact company with any updates or changes in his condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003283852-2019-00001 |
| MDR Report Key | 8233808 |
| Report Source | CONSUMER |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-12-08 |
| Date Mfgr Received | 2019-01-05 |
| Date Added to Maude | 2019-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PRESTIGE BRANDS PV & SAFETY |
| Manufacturer Street | 4615 MURRAY PLACE |
| Manufacturer City | LYNCHBURG VA 24502 |
| Manufacturer Country | US |
| Manufacturer Postal | 24502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTEK MAXIUMUM PROTECTION DENTAL GUARD |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2019-01-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESTIGE BRANDS INC. |
| Manufacturer Address | 4615 MURRAY PLACE LYNCHBURG VA 24502 US 24502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-01-10 |