MAUDE MDR 9716793

MDR report key
9716793
Report number
1417592-2020-00008
Event key
0
Event type
3
Date of event
2020-01-15
Date received
2020-02-17
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
KAREN TRUTSCH
Address
THREE LAKES DRIVE NORTHFIELD, IL US
Phone
643-643-6434
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRANSPORT CHAIR,ALUM, BASIC,12" WHL,REDMEDLINE INDUSTRIES INC.INMMDS808210ARER N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1701. O

Event Narratives#

N

Patient 1

IT WAS REPORTED BY THE CUSTOMER'S DAUGHTER, THAT HER FATHER, TRANSFERRED HER MOTHER, OUT OF THE CAR AND INTO THE TRANSPORT CHAIR WHICH WAS SITTING ON THE DRIVEWAY. CUSTOMER STATED THAT THE DRIVEWAY HAS A SLIGHT INCLINE, HOWEVER AFTER HER FATHER PUT THE BRAKES ON THE TRANSPORT CHAIR AND TURNED AROUND TO GET SOMETHING ELSE OUT OF THE CAR THE BREAKS DID NOT HOLD AND THE CHAIR STARTED TO SLIP DOWN THE DRIVEWAY. THE FATHER REPORTEDLY JUMPED TOWARD THE TRANSPORT CHAIR TO GRAB THE CHAIR BEFORE IT ROLLED DOWN THE DRIVEWAY AND HE FELL TO THE GROUND. THE FATHER WAS ABLE TO GRAB THE BOTTOM OF THE CHAIR TO PREVENT THE CHAIR FROM ROLLING, HOWEVER HE WAS NOT ABLE TO GET BACK UP FROM THE GROUND WITHOUT ASSISTANCE FROM OTHERS. THE FATHER WENT TO HIS PERSONAL CARE DOCTOR FOR FOLLOW UP AND REPORTEDLY HAD X-RAYS PERFORMED AT HIS PERSONAL CARE DOCTOR'S OFFICE. THE CUSTOMER REPORTED THAT HER FATHER REPORTEDLY FRACTURED AN UNKNOWN NUMBER OF RIBS ON HIS LEFT SIDE. THE CUSTOMER DOES NOT KNOW HOW MANY RIBS WERE FRACTURED BUT STATED THERE WAS NO MEDICAL INTERVENTION REQUIRED OR OTHER INJURY NOTED. THE CUSTOMER STATED THAT THERE WAS NO INCIDENT THAT OCCURRED WITH HER MOTHER. THE MOTHER REMAINED IN THE CHAIR WITHOUT INCIDENT OR INJURY. THE CHAIR IS AVAILABLE AND HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT OF THE CUSTOMER'S FATHER EXPERIENCING FRACTURED RIBS AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER REPORTED ISSUE WAS NOT CONFIRMED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

REPORTEDLY, PER THE END USER, THE BRAKES ON THE TRANSPORT CHAIR WERE NOT LOCKING, RESULTING IN THE CUSTOMER FALLING AND FRACTURING AN UNKNOWN NUMBER OF RIBS.