MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-26 for SITTER ELITE 8345 manufactured by Posey Products Llc.
| Report Number | 2020362-2019-00217 |
| MDR Report Key | 9376349 |
| Report Source | USER FACILITY |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-07 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2013-07-29 |
| Date Added to Maude | 2019-11-26 |
| 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 | CHRIS RAHN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514009 |
| 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 | 2019-11-26 |
| Returned To Mfg | 2019-10-31 |
| Model Number | 8345 |
| Catalog Number | 8345 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 2530 LINDSAY PRIVADO DRIVE UNIT A ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-26 |