INOVO INC.
Received Feb 21, 2024 · Event occurred Feb 13, 2023
Report 1062191-2024-00001 · MDR key 18749617
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- Fall
- Fall
Narrative
Description of Event or Problem
INOVO WAS NOTIFIED OF A COMPLAINT INVOLVING A BATH TRANSFER BENCH BY AN END USER'S MOTHER, WHO STATED "THE TUB BASE LEG THAT TELESCOPES WENT IN, GETTING SHORTER [AND] CAUSING MY SON TO FALL IN THE TUB." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE END USER'S MOTHER STATED SHE WILL NOT BE RETURNING THE PRODUCT FOR INVESTIGATION. INOVO WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS. THE MANUFACTURER INCORRECTLY REPORTED THIS ISSUE UNDER FEI (B)(4).
Additional Manufacturer Narrative
INOVO INC. PREVIOUSLY REPORTED THE INCORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER AS 2/13/2023. THE CORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER IS 1/3/2024.