MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-03-29 for RIFTON EQUIPMENT E62 manufactured by Rifton Equipment.
[236188]
Source reports that "while pushing student to the outside play area the rifton stander folded up, dropping pt to back and head on the cement. The toy on the tray slid into the pt's chin and throat area. Pt was pinned under the equipment. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319061-2001-00001 |
| MDR Report Key | 324151 |
| Report Source | 05,06 |
| Date Received | 2001-03-29 |
| Date of Report | 2001-03-27 |
| Date of Event | 2001-03-13 |
| Date Mfgr Received | 2001-03-23 |
| Device Manufacturer Date | 1999-08-01 |
| Date Added to Maude | 2001-04-05 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | D MAAS |
| Manufacturer Street | PO BOX 901 RT 213 |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal | 12471 |
| Manufacturer Phone | 8456588351 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON EQUIPMENT |
| Generic Name | PRONE STANDER |
| Product Code | INW |
| Date Received | 2001-03-29 |
| Model Number | E62 |
| Catalog Number | E62 |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 313620 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | P.O. BOX 901 RT 213 RIFTON NY 12471 US |
| Baseline Brand Name | RIFTON 27" PRONE STANDER |
| Baseline Generic Name | PRONE STANDER |
| Baseline Model No | NA |
| Baseline Catalog No | E62 |
| Baseline ID | NA |
| Baseline Device Family | TABLE, MECHANICAL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-03-29 |