MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-18 for THE DOCTOR'S BRUSHPICKS manufactured by Prestige Brand Holdings, Inc..
[4059284]
A male consumer reported experiencing accidental ingestion while using the doctor's brushpicks (otc dental cleaning instrument). The consumer reportedly started using the doctor's brushpicks for oral care on (b)(6) 2013. The same day the patient experienced possible ingestion. The consumer went to the emergency room at (b)(6) and was admitted for observation. The consumer reported that on (b)(6) 2013 and esophagus scope and chest x-ray were performed. Both tests came back negative. As of (b)(6) 2013 the event had resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719513-2013-00008 |
| MDR Report Key | 3560360 |
| Report Source | 04 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-11-27 |
| Date Mfgr Received | 2013-11-27 |
| Date Added to Maude | 2014-02-05 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 660 WHITE PLAINS RD. STE 250 |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145248700 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE DOCTOR'S BRUSHPICKS |
| Generic Name | DENTAL HAND INSTRUMENT |
| Product Code | JET |
| Date Received | 2013-12-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESTIGE BRAND HOLDINGS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-12-18 |