ADULT CRUTCHES
Received Oct 21, 2014 · Event occurred Jul 1, 2014
Report 2428983-2014-00002 · MDR key 4208933
Device
Generic name
Adult Crutches
Manufacturer
Bliss Health Products Co., Ltd.Model number
3610LF-8Lot number
BMP217MO
Product problems
- Bent
- Detachment Of Device Component
Patient
27 YR
- Fall
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.