MERRY WALKER 900 X 38-09

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-05 for MERRY WALKER 900 X 38-09 manufactured by Innovative Products Unlimited, Inc..

Event Text Entries

[3385] On 11/22/92 resident was placed in the "merry walker" chair and was using the chair in the facility common area; during this use the front wheel of the device caught on the foot pedal of another wheelchair, causing the resident in the "merry walker" to fall foward to the floor. It appears that the construction of this equipment lends itself to be prone to other similar incidents, and was therefore taken out of use after this incident. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: design - human factors. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5656
• MDR Report Key: 5656
• Date Received: 1993-04-05
• Date of Report: 1993-02-23
• Date of Event: 1992-11-22
• Date Facility Aware: 1992-11-22
• Report Date: 1993-02-23
• Date Added to Maude: 1993-07-20
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MERRY WALKER
• Product Code: IMM
• Date Received: 1993-04-05
• Model Number: 900 X 38-09
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Device Age: 01-AUG-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5355
• Manufacturer: INNOVATIVE PRODUCTS UNLIMITED, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-04-05