FDA.reportPublic FDA data

MAUDE MDR 4199249

MDR report key
4199249
Report number
MW5038784
Event key
0
Event type
3
Date received
2014-10-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRIVE MEDICAL HX5 9JPCRUTCHESDRIVE MEDICALIPR10430-110430-1 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-10-210

Event Narratives#

D

Patient 1

INCIDENT DESCRIPTION: MY DAUGHTER INJURED HER ELBOW WHEN HER WWW.DRIVEMEDICAL.COM CRUTCHES COLLAPSED. THE CHEAP PLASTIC PIECE ON THE HAND BAR COLLAPSED. SCHOOL NURSE TRIED TO PAPER TAPE THEM BACK TOGETHER. SHE IS ONLY (B)(6) (WEIGHT LIMIT IS 300 POUNDS), USING THEM CAUTIOUSLY, BUT THE PIN HOLDING THEM AT THE PROPER ADJUSTMENT KEEPS SLIPPING OUT RANDOMLY AS SHE USES THE CRUTCHES. (B)(6) IS REFUSING TO PICK THEM UP AND UNSURE OF HOW TO GET CREDIT OR REPLACE WITH (B)(6). THERE IS NO "CONTACT US" ON THE WEBSITE. TOTALLY CHEAP, UNSAFE DESIGN. PLEASE FILE A COMPLAINT AND SAFETY REPORT WITH THE MFR. INCIDENT LOCATION: SCHOOL. INJURY INFO: INJURY, SEEN BY MED PROFESSIONAL. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2014. EXPLANATION: CAN'T, NO "CONTACT US" ON WEBSITE. (B)(4). REPORT SUBMITTED DATE: 10/14/2014.