FDA.reportPublic FDA data

MAUDE MDR 5286250

MDR report key
5286250
Report number
2183634-2015-00006
Event key
0
Event type
3
Date of event
2015-11-12
Date received
2015-12-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. STACEY FRANK
Address
262 WEST FIRST STREET 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 STRAPSTANDSTANDING FRAMEALTIMATE MEDICAL, INC.IONSTRAPSTAND2000N/AY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-1001. O

Event Narratives#

N

Patient 1

THIS STANDING FRAME IS JUST OVER 4 YEARS OLD AND WAS A REPRESENTATIVE SAMPLE, THEREFORE IT IS ASSUMED THE UNIT WAS USED QUITE FREQUENTLY. THE STRAP FROM THIS ISSUE WAS RETURNED AND VISUALLY INSPECTED. UPON INSPECTION IS WAS DETERMINED THAT THIS STRAP FAILED BECAUSE THE STRAP WAS NOT SEWN ALL THE WAY INTO THE REINFORCED STITCHES ON THE STRAP. THE SALES REPRESENTATIVE REQUESTED AN EXTRA-LARGE ADJUSTABLE SEAT STRAP AS THE REPLACEMENT STRAP FOR THIS UNIT AND THE REPLACEMENT STRAP WAS SHIPPED BY ALTIMATE MEDICAL TO ADDRESS THIS ISSUE.

D

Patient 1

RECEIVED AN EMAIL FROM (B)(6), AN AMI INDEPENDENT REP, THAT THE LARGE ADJUSTABLE SEAT STRAP ON HIS STRAPSTAND SAMPLE UNIT HAD FAILED AND THAT HE NEEDED A REPLACEMENT STRAP. THE FACILITY THAT WAS USING THE STRAPSTAND AT THE TIME HAD A USER THAT WAS APPROXIMATELY (B)(6) LBS. AND WAS ABOUT 45 DEGREES FROM SITTING TO STANDING WHEN ONE SIDE OF THE STRAP TORE AWAY FROM THE BODY OF THE SEAT STRAP. THE USER HAD BEEN SITTING ON A HIGH-LOW MAT (GYM MAT), THEREFORE WHEN THE STRAP TORE AWAY THE USER WAS SUPPORTED BY THE MAT UNDERNEATH THEM. NO INJURIES TO THE USER.