MERITS
Received Apr 8, 2021 · Event occurred Mar 2, 2021
Report 9680333-2021-00002 · MDR key 11637771
Device
Product problems
- Fracture
- Fracture
Patient
65 YR
- Fall
- Fall
Narrative
Description of Event or Problem
PATIENT WAS AT HER NEIGHBOR'S HOUSE AND AS SHE LEFT HER DRIVEWAY THAT HAD SLIGHT INCLINE THE SEAT POST OF THE CHAIR SHEARED OFF CAUSING HER TO FALL OUT OF THE CHAIR WITH THE SEAT ON TOP OF HER CAUSING INJURY. SHE DID NOT WANT TO GO TO THE HOSPITAL DUE TO COVID. NO AMBULANCE WAS CALLED, HER NEIGHBOR JUST BROUGHT HER INTO THE HOUSE. SHE HAVE A DR'S APPOINTMENT (B)(6) 8:00 AM.
Additional Manufacturer Narrative
THERE WAS A TYPING ERROR IN THE MODEL NAME OF THE DEVICE IN THE ORIGINAL SUBMISSION FILE (B)(4). THE MODEL NUMBER FOR THE DEVICE IS P326A.
Description of Event or Problem
PATIENT WAS AT HER NEIGHBOR'S HOUSE AND AS SHE LEFT HER DRIVEWAY THAT HAD SLIGHT INCLINE THE SEAT POST OF THE CHAIR SHEARED OFF CAUSING HER TO FALL OUT OF THE CHAIR WITH THE SEAT ON TOP OF HER CAUSING INJURY. SHE DID NOT WANT TO GO TO THE HOSPITAL DUE TO COVID. NO AMBULANCE WAS CALLED, HER NEIGHBOR JUST BROUGHT HER INTO THE HOUSE. SHE HAVE A DR'S APPOINTMENT 3/4 8:00 AM
Remedial action
- Replace