MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-02-27 for RIFTON PRONE STANDER E93 manufactured by Rifton Equipment.
[3297022]
Source reported that child was removed from product while biting on tray, resulting in broken jaw and several teeth lost.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319061-2008-00001 |
| MDR Report Key | 3003921 |
| Report Source | 00 |
| Date Received | 2008-02-27 |
| Date of Report | 2008-02-19 |
| Date of Event | 2007-12-21 |
| Date Mfgr Received | 2007-02-04 |
| Date Added to Maude | 2013-03-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRK WAREHAM |
| Manufacturer City | RIFTON NY |
| Manufacturer Country | US |
| Manufacturer Phone | 8456587723 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON PRONE STANDER |
| Generic Name | PRONE STANDER |
| Product Code | INW |
| Date Received | 2008-02-27 |
| Model Number | E93 |
| Catalog Number | E93 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | RIFTON NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-02-27 |