FDA.reportPublic FDA data

MAUDE MDR 4210250

MDR report key
4210250
Report number
1825014-2014-00015
Event key
0
Event type
3
Date of event
2014-10-01
Date received
2014-10-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Address
5000 36TH ST., S.E. GRAND RAPIDS MI 49512 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SKYTRONSURGICAL TABLEMIZUHOBWN3502 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-10-2101. R

Event Narratives#

D

Patient 1

THE PT WA REVERSED ON THE TABLE AND THE PT'S WEIGHT WAS NOT EVENLY DISTRIBUTED. THIS LEAD TO THE TABLE TIPPING AND REQUIRED THE HOSPITAL STAFF TO CATCH THE PT TO PREVENT INJURY TO THE PT. HOSPITAL STAFF RECOGNIZED IMPROPER USE WAS THE CONTRIBUTING FACTOR TO THE INCIDENT.