MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-07-30 for DAILY ACTIVITY ASSIST DEVICES 6497 manufactured by Unknown.
[20221703]
Consumer called stating that the left side of the seat on her 6497 commode allegedly cracked from a bracket screw. The right side tubing that connects to the seat is allegedly cracking also. The consumer has been utilizing this commode since 2009. No injury alleged.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1531186-2012-00620 |
MDR Report Key | 2674360 |
Report Source | * |
Date Received | 2012-07-30 |
Date of Report | 2012-07-27 |
Date Facility Aware | 2012-07-02 |
Report Date | 2012-07-27 |
Date Reported to FDA | 2012-07-27 |
Date Added to Maude | 2012-11-20 |
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 | PATIENT |
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 | 2012-07-30 |
Model Number | 6497 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | UNKNOWN |
Manufacturer Address | OH US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2012-07-30 |