FDA Adverse Event Injury Summary report: N

COMPASS HEALTH BRANDS

MDR report key: 14192523 · Received April 25, 2022

Report

Report Number: 3012316249-2022-00008
Event Type: Injury
Date Received: April 25, 2022
Report Date: May 26, 2022
Manufacturer: SICHUAN QILI ENTERPRISE INC.
Product Code: INM
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Description of Event or Problem · 0

HE WAS GETTING OUT OF A PICKUP TRUCK INTO THE CHAIR AND THE CHAIR BOUNCED AND FELL BACKWARDS. HE WAS KNOCKED UNCONSCIOUS AND TAKEN BY AMBULANCE TO THE EMERGENCY ROOM. HE HAD A BRAIN SCAN. HE HAD BRAIN BLEEDING. NO STITCHES. BRUISING ON HIS HEAD. HE WAS KEPT 24 HOURS FOR OBSERVATION AND THEN RELEASED. HE WAS GIVEN SOME MEDICATION BUT HE DOES NOT KNOW WHAT IT IS. HE DOES NOT KNOW IF THERE IS FOLLOW UP CARE REQUIRED. DURING PHONE CALL HE SAID HIS WIFE WAS HELPING HIM GET OUT OF A PICK-UP TRUCK INTO THE CHAIR. DEVICE IS A TRANSPORT CHAIR WHICH REQUIRES A CAREGIVER HOLDING THE CHAIR FROM BEHIND DURING OPERATION.

Description of Event or Problem · 0

DEVICE RETURNED FOR INSPECTION: TRANSPORT CHAIR WAS RETURNED WITH ALL THE NECESSARY COMPONENTS. LEFT LOWER LEG WHEEL WOULD NOT LATCH IN, FROM THE MANS FALL THE TUBE WAS EXTREMELY BENT. YOU WOULD NEED SOMETHING STRONG TO BEND IT BACK TO FIT IN THE WHEEL AND SCREW. ·THE RIGHT LOWER LEG AND ALSO THE LEFT BACK WHEEL WERE NOT BENT AND I WAS ABLE TO FIT THEM PROPERLY. THE LEFT INNER BAR HAS EXTENSIVE DAMAGE FROM THE FALL AND THE BAR IS ALL SCRATCHED UP, REST OF THE CHAIRS BARS HAS MINOR WEAR AND SCRAPES. FROM MY FINDINGS I CAN CONFIRM THAT THE CUSTOMERS COMPLAINT IS CONFIRMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
199098	COMPASS HEALTH BRANDS	TRANSPORT CHAIR	INM	SICHUAN QILI ENTERPRISE INC.	FGA33677 0000

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Hospitalization