FDA Adverse Event Injury Summary report: N

TILT IN SPACE

MDR report key: 9581705 · Received January 13, 2020

Report

Report Number: 9616091-2020-00002
Event Type: Injury
Date Received: January 13, 2020
Report Date: December 16, 2019
Manufacturer: INVAMEX MANUFACTURING
Product Code: IOR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

INVACARE WAS MADE AWARE OF THIS EVENT THAT OCCURRED IN (B)(6) WITH A REA AZALEA WHEELCHAIR. THIS RECORD WAS CREATED DUE TO THE US MANUFACTURED SOLARA 3G BEING A SIMILAR DESIGN AS THE REA AZALEA AND WOULD BE LIKELY TO HAVE THE SAME ADVERSE OUTCOME AS THIS EVENT. THE DEVICE WASN'T ORDERED WITH CALF OR HEEL STRAPS. LEG-REST, FOOTREST, HEEL STRAPS, AND CALF STRAPS, ARE AVAILABLE ON THE PRESCRIPTION FORM AND ON THE SPARE PART CATALOG. WHEN A LEG-REST IS ORDERED, THE FOOTREST IS PROVIDED WITH MOUNTED HEEL STRAP. THE REA AZALEA WHEELCHAIR HAS NOT BEEN RETURNED TO INVACARE FRANCE FOR AN EVALUATION, HOWEVER IT WAS RETURNED TO THE DEALER, WHO STATED: "THERE IS NOTHING TECHNICALLY WRONG WITH THE PRODUCT." THEY ADDED HEEL AND CALF STRAPS AND RETURNED IT TO THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

Description of Event or Problem · 1

THE SON WAS TAKING THE PATIENT (WHO HAS IMPAIRED SENSATION IN HIS LEG) FOR A WALK IN HIS REA AZALEA WHEELCHAIR. WHEN THEY WERE GOING UP ON THE SIDEWALK, AND THE PATIENT'S LEFT FOOT SLID BACKWARD ON THE FOOTPLATE, AND THEN OFF THE FOOTPLATE. THE PATIENT'S FOOT GOT STUCK BETWEEN THE WHEELCHAIR AND THE CURB. THEY SUFFERED A LOWER LEG FRACTURE AND WERE TREATED WITH A PLASTER CAST FOR 8 WEEKS. THE WHEELCHAIR DID NOT HAVE CALF SUPPORTS AND HEEL STRAPS ON IT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
46685	TILT IN SPACE	WHEELCHAIR, MANUAL	IOR	INVAMEX MANUFACTURING	NA:SOLARA3G

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention