UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-11 for UNKNOWN manufactured by Unknown.

Event Text Entries

[2120] While assisting patient back to bed nurse bumped her head on overhead trapeze bar. About the same time the other end of the trapeze fell sstiking the patient on the head. The bar at the foot of the bed was not locked in latch and the bar at the head of the bed was loosely placed in latch. Within a few moments of occurrence patient had a seizure, possibly pseudo seizure. Ct was negative and patient was dismissed the following day. This facility uses several different makes of frames and no one has specific recall as to the type of frame in usedevice not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3549
• MDR Report Key: 3549
• Date Received: 1992-12-11
• Date of Report: 1992-12-11
• Date of Event: 1992-12-02
• Report Date: 1992-12-11
• Date Added to Maude: 1993-04-23
• 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: UNKNOWN
• Generic Name: TRAPEZE BAR - OVERHEAD FRAME
• Product Code: IOE
• Date Received: 1992-12-11
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 3291
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-12-11