FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2760085
·
Received September 26, 2012
Report
- Report Number
- 1531186-2012-01012
- Date Received
- September 26, 2012
- Date of Event
- August 27, 2012
- Report Date
- September 25, 2012
- Manufacturer
- POPULAR PLASTICS
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
MDR DECISION DATE: (B)(6) 2012. NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THAT PATIENT WAS USING THE SHOWER CHAIR ON (B)(6) 2012. HE ALLEGES THAT THE PATIENT LEANED BACK AND THE BACK OF THE SHOWER CHAIR CAME COMPLETELY OFF. DEALER STATES THE THERAPIST CAUGHT THE PATIENT TO AVOID INJURY. DEALER STATES THAT THERAPIST PUT THE BACK ON, AND THE SAME INCIDENT HAPPENED AGAIN. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | POPULAR PLASTICS | 9670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 | Other |