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MAUDE MDR 1016489

MDR report key
1016489
Report number
1016489
Event key
0
Event type
3
Date of event
2008-02-28
Date received
2008-03-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OFFEST DOUBLE CLAMPTRAPEZE, HOSPITAL BEDZIMMER ORTHOPAEDIC SURGICAL PRODUCTSILZ00-1238-004-0000-1238-004-00*N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-03-030

Event Narratives#

D

Patient 1

THE PATIENT WAS ON HER BED BEING TRANSPORTED TO THE OR. AS THE TRANSPORTER WAS PUSHING THE BED INTO THE HALL, THE BED WENT OVER A BUMP IN THE FLOOR WHERE CARPET MET HARD FLOORING. THE TRAPEZE BOLT HANGING ABOVE THE PATIENT SHEARED OFF AND THE TRIANGULAR PART OF THE TRAPEZE FELL ON THE PATIENT'S HEAD. THE TRAPEZE IS AN ORTHO DEVICE ATTACHED TO AN OVERHEAD BAR AT THE HEAD OF THE BED. THIS TRIANGULAR BAR FELL ON THE PATIENT'S HEAD. IT WAS DESCRIBED AS A 'KNOT' ON THE PATIENT'S HEAD AND ICE WAS APPLIED. THERE WERE NO DEFICITS NOTED. THE PATIENT PROCEEDED TO THE OR, COMPLETED THE SURGERY SATISFACTORILY. IT APPEARS THAT THE MANUFACTURER HAS MADE A DESIGN CHANGE AT SOME POINT BUT THE PART NUMBER HAS REMAINED THE SAME. THE PART REPORTED IN THIS EVENT IS FROM THE OLD DESIGN. IN THE NEW DESIGN THE BOLT APPEARS TO BE THICKER AND WIDER.