MAUDE MDR 3876255

MDR report key
3876255
Report number
3007494904-2014-00001
Event key
0
Event type
3
Date received
2014-06-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
5848 DIXIE HIGHWAY SAGINAW MI 48601 US
Phone
989-989-9897
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUPERSTANDSTAND UP WHEELCHAIRTHE STANDING COMPANYIPLHPS-2Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-1601. H

Event Narratives#

D

Patient 1

ON (B)(6) 2014, THE STANDING COMPANY WAS NOTIFIED BY THE CASE MANAGER OF THE QUADRIPARESIS CLIENT THAT THE CLIENT HAD BEEN HOSPITALIZED. ACCORDING TO THE CASE MANAGER, THE CLIENT SAID HE WAS ATTEMPTING TO DO PUSH-UPS (I.E. STRENGTHEN HIS UPPER BODY AND/OR TO PROVIDE RELIEF TO HIS SKIN) WHILE IN HIS WHEELCHAIR. THE CASE MANAGER SAID THE CLIENT SAID HE HAD HIS TIBIA SUPPORTS ON/INSTALLED, BUT DID NOT HAVE THE ARMREST PROPERLY PLACED IN FRONT OF HIM NOR DID HE HAVE HIS SEAT BELT FASTENED. THE CASE MANAGER STATED THE CLIENT SAID AS HIS CHAIR STARTED MOVING UPWARD THAT "HE (THE CLIENT) PANICKED". HE INADVERTENTLY LEANED FORWARD AND GRABBED FOR "SOMETHING". THE CLIENT SAID HE THEN FELL FORWARD. THE CLIENT BROKE HIS RIGHT TIBIA PLATEAU (RIGHT LOWER LEG NEAR KNEE). THE CLIENT, ACCORDING OT THE CASE MANAGER WAS TRANSPORTED TO A LOCAL HOSPITAL ON (B)(6) 2014 AND HAD SURGERY ON BOTH LEGS TO STABILIZE THE FRACTURE. THE CLIENT WILL THEN BE IN REHAB FACILITY FOR A LENGTH OF TIME.

N

Patient 1

BASED ON WHAT THE CASE MANAGER STATED THE CLIENT SAID, THE STANDING COMPANY HAS ATTEMPTED TO DUPLICATE CLIENT'S PROBLEM BUT UNABLE TO DO SO. THE STANDING COMPANY'S SERVICE MANAGER, A T-7 PARAPLEGIC WHO ON A DAILY BASIS USES THE EXACT SAME WHEELCHAIR THE CLIENT USES, CANNOT - BASED ON WHAT THE CASE MANAGER STATED THE CLIENT SAID - RECREATE THE INCIDENT. THE CASE MANAGER SAYS SHE AND THE CLIENT - UPON HIS RETURN HOME - WANT TSC TO (ONCE AGAIN) PROVIDE THE CLIENT WITH A REFRESHER COURSE REGARDING CHAIR OPERATION. WE WILL COMPLY. ON (B)(4) 2014, A REPRESENTATIVE FROM THE STANDING WHEELCHAIR COMPANY (TSC) VISITED WITH THE WIFE OF THE CLIENT. DURING THIS TIME THE REPRESENTATIVE OF TSC INSPECTED THE CHAIR. HE DROVE CHAIR AND INSPECTED THE STANDING MECHANISM BY GOING UP AND DOWN IN CHAIR. HE ALSO ASSESSED THE ARMREST AND THE SEATBELT FOR ANY ISSUES. NO ISSUES WERE FOUND. THE EVALUATIONS DEEMED THE CHAIR TO BE FULLY FUNCTIONING AND IN GOOD WORKING ORDER.