MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-11-27 for DAILY ACTIVITY ASSIST DEVICES 6497 manufactured by Jan Mao.
[17977753]
(b)(4). No serious injury alleged. Malfunction alleged. Dealer states this is a commode they rent out. He says the frame is bent now preventing the seat from laying flat on frame. He states the users were within weight capacity. Mdr filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2012-01503 |
| MDR Report Key | 2847535 |
| Report Source | * |
| Date Received | 2012-11-27 |
| Date of Report | 2012-11-27 |
| Date Facility Aware | 2012-10-29 |
| Report Date | 2012-11-27 |
| Date Reported to FDA | 2012-11-27 |
| Date Reported to Mfgr | 2012-11-27 |
| Date Added to Maude | 2013-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAILY ACTIVITY ASSIST DEVICES |
| Generic Name | 890.5050 |
| Product Code | INB |
| Date Received | 2012-11-27 |
| Model Number | 6497 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAO |
| Manufacturer Address | HUIZHOU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-27 |