FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 3549 · Received December 11, 1992

Report

Report Number
3549
Event Type
Injury
Date Received
December 11, 1992
Date of Event
December 2, 1992
Report Date
December 11, 1992
Manufacturer
UNKNOWN
Product Code
IOE
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNKNOWN TRAPEZE BAR - OVERHEAD FRAME IOE UNKNOWN UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention