RIFTON E94/980209AA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-03 for RIFTON E94/980209AA manufactured by Rifton Equipment.

Event Text Entries

[107029] According to the rptr, this prone stander was purchased approx two weeks ago. It is the second stander purchased from this co by the rptr. The stander is used to allow people to weight bear who otherwise are unable to stand. The rptr strapped her daughter into the device while she was working in the garage. Her daughter proceeded to grab the velcro restraint and pull. The velcro restaint opened and her daughter fell hitting her head on the concrete floor. The daughter sustained a laceration which required sutures to close. The daughter also experienced vomiting, but no severe head injury was discovered. The rptr states the design between the two standers they own is different. The first stander they purchased used two straps which clipped into place much like a seat belt. In order to release the straps, the sides of the locking mechanism must be depressed. The new stander uses a "very weak" velcro strap which is easily released by pulling therefore the person is not adequately secured. The co has offered to buy back the device, but the rptr feels the issue of the safety hazard will not be addressed and someone might sustain a serious injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1013422
• MDR Report Key: 160776
• Date Received: 1998-04-03
• Date of Report: 1998-04-03
• Date of Event: 1998-03-30
• Date Added to Maude: 1998-04-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RIFTON
• Generic Name: PRONE STANDER
• Product Code: IPL
• Date Received: 1998-04-03
• Model Number: E94/980209AA
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 156568
• Manufacturer: RIFTON EQUIPMENT
• Manufacturer Address: RT. 213 P.O. BOX 901 RIFTON NY 12471 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-04-03