MAUDE MDR 8550943

MDR report key
8550943
Report number
1417592-2019-00049
Event key
0
Event type
3
Date received
2019-04-25
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
NIGEL VILCHES
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Phone
224-224-2249
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CANE, QUAD, SMALL BASE, BRONZEMEDLINE INDUSTRIES INC.IPSMDS86222BRZR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-2501. R

Event Narratives#

N

Patient 1

REPORTEDLY, THE END-USER HAS CAUGHT THE QUAD CANE IN REVOLVING DOORS IN THE PAST AND THE DEVICE TYPICALLY LEANS TO THE SIDE. ON THE DATE OF THE INCIDENT, THE QUAD CANE "TWISTED COMPLETELY" AS THE END-USER WAS WALKING AND SHE EXPERIENCED A FALL. THE END-USER WAS ABLE TO GET HERSELF BACK UP AFTER THE FALL AND SHE WENT TO HER LOCAL HOSPITAL'S EMERGENCY DEPARTMENT (ED). UNIDENTIFIED DIAGNOSTIC EXAMS WERE PERFORMED AND THE END-USER STATED THAT SHE WAS TOLD THAT SHE DID NOT EXPERIENCE A FRACTURE. NO ED MEDICAL TREATMENTS WERE REPORTED TO THE MANUFACTURER. THE END-USER WAS DISCHARGED HOME FROM THE ED AND FOLLOWED UP WITH A SPECIALIST WHO PRESCRIBED HER PHYSICAL THERAPY. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINE. DUE TO THE NEED FOR FOLLOW-UP MEDICAL CARE, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT THE END-USER EXPERIENCED A FALL AND WAS REQUIRED TO HAVE PHYSICAL THERAPY.