REAR HOLD DOWN UNIT 1202 REAR UNIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-16 for REAR HOLD DOWN UNIT 1202 REAR UNIT manufactured by Creative Controls, Inc..

Event Text Entries

[21716293] Wheelchair restraint straps loosened during van transport of patient in wheelchair. Patient and wheelchair tipped overinvalid data - regarding single use labeling of device. 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: other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2762
• MDR Report Key: 2762
• Date Received: 1992-09-16
• Date of Report: 1992-04-27
• Date of Event: 1992-04-14
• Date Facility Aware: 1992-04-14
• Report Date: 1992-04-27
• Date Reported to Mfgr: 1992-04-27
• Date Added to Maude: 1993-03-26
• 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: REAR HOLD DOWN UNIT
• Product Code: KNO
• Date Received: 1992-09-16
• Model Number: 1202 REAR UNIT
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 2577
• Manufacturer: CREATIVE CONTROLS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-09-16