MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-22 for REDSENSE ALARM manufactured by Redsense Med Inc.
[22236698]
Redsense alarm failed to alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018309 |
| MDR Report Key | 1908974 |
| Date Received | 2010-11-22 |
| Date of Report | 2010-11-22 |
| Date of Event | 2010-11-19 |
| Date Added to Maude | 2010-12-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDSENSE ALARM |
| Generic Name | NONE |
| Product Code | ODX |
| Date Received | 2010-11-22 |
| Lot Number | M0100308AA |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REDSENSE MED INC |
| Manufacturer Address | 150 MICHIGAN AVE CHICAGO IL 60601 US 60601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-22 |