FDA Adverse Event Injury Summary report: N

COMPASS HEALTH BRANDS

MDR report key: 10020856 · Received May 4, 2020

Report

Report Number
3012316249-2020-00017
Event Type
Injury
Date Received
May 4, 2020
Date of Event
April 14, 2020
Report Date
May 4, 2020
Manufacturer
JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
Product Code
IOR
Adverse Event
Yes
Product Problem
Yes
Report Source
Distributor report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT CUT HER LEG ON THE PART WHERE THE LEGREST FITS ONTO THE WHEELCHAIR. THEY REMOVED THE LEGREST WHEN MOVING HER IN AND OUT OF THE CHAIR. SAID THE HOOK HAS A SHARP EDGE. THE DAUGHTER SAID THE MOM WAS CUT AND NEEDED STITCHES. PER MEDWATCH FORM: MY MOTHER LIVES AT AN ASSISTANT LIVING FACILITY. SHE WAS ATTEMPTING TO GET INTO HER WHEELCHAIR (DIRECT SUPPLY WHEELCHAIR WITH SWINGING LEG REST), WITH THE NURSES AID STANDING NEXT TO HER. THE SWINGING FOOT REST WAS OFF THE CHAIR TO PREVENT FALLS, EXPOSING THE LOCKING PIN AND MOUNTING PIN FOR LEG REST ATTACHMENT (PARTS ON WHEELCHAIR WHERE FOOT REST CLICKS INTO PLACE). WHEN SHE SAT DOWN, THE METAL PINS SEVERELY CUT HER LEG IN A "T" SHAPE. SHE WAS RUSHED TO ER WHERE SHE RECEIVED APPROXIMATELY 2 DOZEN STITCHES (POSSIBLY MORE, DOCTOR SAID SHE WAS PLEASED THAT SHE WAS ABLE TO GET THE SKIN TO COME BACK TOGETHER), TETANUS SHOT, PLUS ANTIBIOTICS. SHE HAS SIGNIFICANT CO-MORBIDITY (LYMPHEDEMA, ETC.) THAT WILL IMPACT HER ABILITY TO HEAL (HISTORY OF MINOR SCRATCHES TO LETS VERY SLOW TO HEAL AND HAVING COMPLICATIONS). WE DO NOT HAVE ANYTHING TO COVER THE EXPOSED METAL OR HINDER ATTACHMENT OF LEG REST WHEN NEEDED TO USE BY MY MOTHER. I TALKED TO THE FACILITIES PT THIS MORNING AND SHE SAID THAT ALL WHEELCHAIRS HAVE REST SWINGS AND YOU CAN PUSH IT TO THE SIDE, IT STILL SWINGS BACK, GETTING IN THE WAY AND CAN CAUSE POSSIBLE FALLS OR HIT THE PATIENT'S FOOT WHILE ATTEMPTING TO GET IN THE CHAIR OR SIT IN THE CHAIR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
484450 COMPASS HEALTH BRANDS WHEELCHAIR IOR JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. PAN20RFR

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention