FDA.reportPublic FDA data

MAUDE MDR 5974221

MDR report key
5974221
Report number
3004763499-2016-00007
Event key
0
Event type
3
Date of event
2016-08-11
Date received
2016-09-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAMIE BRADSHAW
Address
5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US
Phone
470-470-4703
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TORTOISE POSITIONING SYSTEMDEVICE, TRANSFER, PATIENT, MANUALMOLNLYCKE HEALTHCAREFMRSUN TORT100* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-2301. R

Event Narratives#

D

Patient 1

A FACILITY REPORTED THAT A PATIENT WAS BEING REPOSITIONED BY A PCA, NOT AN RN. WHEN THE PCA PULLED ON THE HANDLES OF THE POSITIONER, THE PATIENT ROLLED OUT OF BED, OVER THE GUARD RAIL, FELL TO THE FLOOR AND BROKE THEIR SHOULDER. MULTIPLE REQUESTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED AT THE TIME OF THIS REPORT.