MAUDE MDR 9683332

MDR report key
9683332
Report number
1417592-2020-00009
Event key
0
Event type
3
Date of event
2019-10-26
Date received
2020-02-07
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 60093 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROLLATOR, STEEL, KNOCK-DOWNMEDLINE INDUSTRIES INC.ITJMDS86850ESKDR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0701. O

Event Narratives#

N

Patient 1

IT WAS REPORTED THAT WHILE USING A ROLLATOR, THE DEVICE BROKE AND THE END USER FELL. THE END USER REPORTED THAT HE WAS WALKING ON CONCRETE WITH THE ROLLATOR AND THE RIGHT REAR WHEEL BROKE IN 2 RESULTING IN HIM FALLING BACKWARDS. THE END USER STATED THAT THE CAB DRIVER HELPED HIM UP AND HELPED HIM INTO THE CAB TO GET HIM BACK TO HIS HOUSE. THE END USER REPORTED THAT HE DID NOT GO TO THE DOCTOR OR HOSPITAL AFTER THE EVENT OCCURRED. THE END USER STATED THAT THE FALL HAPPENED ON (B)(6) 2019 AND 3-4 DAYS LATER HE WENT TO A FOLLOW UP APPOINTMENT WITH A DOCTOR THAT HE HAD BEEN SEEING FOR A LEG INJURY THAT HE SUSTAINED 2 YEARS PRIOR FOR AN UNRELATED INCIDENT. REPORTEDLY, THE DOCTOR TOOK X-RAYS OF THE PREVIOUS LEG INJURY TO SEE IF THERE WAS A DISRUPTION OF THE PREVIOUS INJURY AND FOUND THERE WAS NO DISRUPTION OF THE PREVIOUS INJURY AND NO FRACTURE NOTED. THE END USER REPORTED THAT THE DOCTOR DID NOT EVALUATE THE END USER FOR ANY BACK INJURY OR BACK PAIN. THE END USER STATED THAT AFTER AN UNREPORTED NUMBER OF DAYS HE STARTED FEELING BACK PAIN, WENT THROUGH THE YELLOW PAGES OF THE PHONE BOOK AND FOUND A DIFFERENT DOCTOR THAT HE WENT TO FOR EVALUATION OF BACK PAIN THAT HE WAS HAVING. THE END USER REPORTED THAT HE WENT TO THE DOCTOR FOR EVALUATION AND AFTER HAVING X-RAYS AND AN MRI THE DOCTOR TOLD THE END USER THAT HE HAS AN UNSPECIFIED FRACTURE IN HIS BACK. REPORTEDLY, NO ADDITIONAL INFORMATION RELATED TO THE FRACTURE WAS REPORTED TO THE PATIENT, BUT HE THINKS IT IS FROM THE FALL. 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. DUE TO THE REPORTED INCIDENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

REPORTEDLY PER THE END USER, THE BACK WHEEL OF THE ROLLATOR BROKE CAUSING HIM TO FALL AND FRACTURE HIS BACK.