MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-15 for SITTER ELITE 8345 manufactured by .
Report Number | 2020362-2019-00176 |
MDR Report Key | 8896349 |
Report Source | USER FACILITY |
Date Received | 2019-08-15 |
Date of Report | 2019-07-24 |
Date Mfgr Received | 2019-07-24 |
Device Manufacturer Date | 2017-03-13 |
Date Added to Maude | 2019-08-15 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | WILLIAM HINCY |
Manufacturer Street | 5635 PECK ROAD |
Manufacturer City | ARCADIA CA 91006 |
Manufacturer Country | US |
Manufacturer Postal | 91006 |
Manufacturer Phone | 6264433143 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SITTER ELITE |
Generic Name | FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED |
Product Code | PJO |
Date Received | 2019-08-15 |
Returned To Mfg | 2019-08-05 |
Model Number | 8345 |
Catalog Number | 8345 |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer Address | US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-15 |