RIFTON 35" PRONE STANDER NI E65

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-25 for RIFTON 35" PRONE STANDER NI E65 manufactured by Rifton Equipment.

Event Text Entries

[21034949] Child put in prone stander. While feet, child's elbow got wedged between tray and stander, and was bruised.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1319061-1996-00002
• MDR Report Key: 52266
• Report Source: 05
• Date Received: 1996-11-25
• Date of Report: 1996-11-22
• Date of Event: 1996-10-01
• Date Mfgr Received: 1996-10-08
• Date Added to Maude: 1996-12-02
• 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: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RIFTON 35" PRONE STANDER
• Generic Name: 35" PRONE STANDER
• Product Code: FNW
• Date Received: 1996-11-25
• Model Number: NI
• Catalog Number: E65
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 52918
• Manufacturer: RIFTON EQUIPMENT
• Manufacturer Address: RT 123 RIFTON NY 12471 US
• Baseline Brand Name: RIFTON 35" PRONE STANDER
• Baseline Generic Name: 35" PRONE STANDER
• Baseline Model No: NA
• Baseline Catalog No: E65
• Baseline ID: NA
• Baseline Device Family: TABLE, MECHANICAL
• Baseline Shelf Life Contained: A
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K892700
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-11-25