MAUDE MDR 4208933

MDR report key
4208933
Report number
2428983-2014-00002
Event key
0
Event type
3
Date of event
2014-07-01
Date received
2014-10-21
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
SYBIL CHEN
Address
NO. 96M ZHAOYI RD. DONSHEN TOWN, ZHONGSHAN CITY 30106 CH
Phone
602-602-6022
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADULT CRUTCHESBLISS HEALTH PRODUCTS CO., LTD.IPR3610LF-8BMP217MO* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-10-2101. R

Event Narratives#

D

Patient 1

CLAIMANT STATES THAT SHE WAS WALKING ON THE SIDEWALK USING HER CRUTCHES WHEN ONE OF THE CRUTCHES FELL APART AT THE HAND GRIP CAUSING HER TO FALL. SHE ALLEGES THE RECENTLY INSERTED PINS IN FOUR SMALL TOES (LEFT FOOT) WERE BENT. SHE ANTICIPATES HAVING THE PINS REPAIRED IN (B)(6) 2015 WHEN THE WEATHER PERMITS. SHE STATED THE CRUTCHES WERE PURCHASED AT A PHARMACY THE DAY BEFORE THE INCIDENT WRAPPED IN PLASTIC. HER SURGEON FITTED THE CRUTCHES PRIOR TO HER USE. NO MEDICAL SUBSTANTIATION HAS BEEN RECEIVED.

N

Patient 1

THE CLAIMANT RETURNED THE PRODUCT TO A AND M PHARMACY AND SURGICAL SUPPLIES FOLLOWING THE ALLEGED INCIDENT. ON (B)(6) 2014 A AND E PHARMACY (DAPESH) STATED THE HANDGRIP BOLT AND WING NUT WERE NOT RETURNED AND THEY NEEDED AUTHORIZATION FROM KINRAY (PHARMACY SUPPLIER) TO RETURN THE CRUTCHES TO GF HEALTH PRODUCTS, INC. FOR EVALUATION. TODAY, 10/21/2014, THE PHARMACY STATED THE CRUTCHES WERE THROWN AWAY. HANG TAG ATTACHED TO CRUTCHES: SAFETY GUIDELINES - PLEASE READ BEFORE USE. WARNING: WING NUTS MUST BE TIGHT AT ALL TIMES. WARNING: IF COMPONENTS ARE DAMAGED OR MISSING, CONTACT YOUR DISTRIBUTOR IMMEDIATELY.