FDA.reportPublic FDA data

MAUDE MDR 4490879

MDR report key
4490879
Report number
2183634-2015-00001
Event key
0
Event type
3
Date of event
2015-01-06
Date received
2015-02-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STACEY FRANK
Address
262 WEST FIRST ST. MORTON MN 56270 US
Phone
507-507-5076
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EASYSTAND EVOLV890.3110ALTIMATE MEDICAL, INC.IONEVOLV MEDIUMNG50162NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-02-040

Event Narratives#

D

Patient 1

ON (B)(6) 2015, ALTIMATE MEDICAL (AMI) CUSTOMER SVC RECEIVED A CALL FROM A FACILITY REGARDING A BROKEN THREAD ON A CASTER. THE FOLLOWING ADD'L INFO WAS OBTAINED ON (B)(6) 2015 FROM THE FACILITY: THE THREAD ON ONE OF THE BACK CASTERS BROKE AND THE BACK END OF THE FRAME WENT DOWN TO THE FLOOR., CAUSING THE STANDER TO BE UNEVEN. THE TEACHER SAW THIS AND HELPED THE CHILD IN THE UNIT LAY ON THE FLOOR. HELP ARRIVED AND THREE PEOPLE THEN STOOD THE STANDER BACK UP AND TWO MORE LIFTED THE CHILD OUT OF THE STANDER. THE NURSING STAFF AT THIS FACILITY CHECKED OVER THE CHILD AND HE APPEARED TO BE OK, HOWEVER, THE PARENT OF THE CHILD WANTED HIM TAKEN TO THE EMERGENCY ROOM BY AMBULANCE TO BE FURTHER CHECKED OUT. ON (B)(6) 2015 ATTEMPTS WERE MADE TO GATHER FURTHER INFO BUT THE FACILITY WAS UNABLE TO PROVIDE ANY FURTHER INFO AT THE TIME.

N

Patient 1

ON F/U ATTEMPTS TO OBTAIN ADD'L INFO, THE FACILITY HAS BEEN UNABLE TO PROVIDE ADD'L INFO AT THIS TIME. HOWEVER, THE FACILITY STATED THEY WILL KEEP IN CONTACT WITH AMI AND LET US KNOW WHEN THEY CAN PROVIDE ADD'L INFO. IN ADDITION, AMI HAS REQUESTED TO HAVE THE CASTER AND THE BASE RETURNED SO THIS ISSUE CAN BE INVESTIGATED. THE FACILITY IS UNABLE TO RETURN THE COMPONENTS AT THIS TIME BUT STATED IT WILL F/U WITH AMI IF AND/OR WHEN THEY CAN RETURN THE COMPONENTS TO AMI.