MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-04-14 for RIFTON 42" PRONE STANDER E94 manufactured by Rifton Equipment.
[15006675]
Source reports that child reached around and undid strap, causing her to fall backwards out of the prone stander. Child allegedly hit her head on the cement floor, resulting in vomiting and lethargy. Source reports that child has fully recovered and no negative effects from incident apparent from cat scans.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319061-1998-00003 |
| MDR Report Key | 162946 |
| Report Source | 04 |
| Date Received | 1998-04-14 |
| Date of Report | 1998-04-06 |
| Date of Event | 1998-04-01 |
| Date Mfgr Received | 1998-04-02 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 1998-04-20 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON 42" PRONE STANDER |
| Generic Name | PRONE STANDER |
| Product Code | INW |
| Date Received | 1998-04-14 |
| Model Number | E94 |
| Catalog Number | E94 |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 158649 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | RT. 213 RIFTON NY 12471 US |
| Baseline Brand Name | RIFTON 42" PRONE STANDER |
| Baseline Generic Name | 42" PRONE STANDER |
| Baseline Model No | NA |
| Baseline Catalog No | E94 |
| 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. Life Threatening | 1998-04-14 |