MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-30 for STRYKER AIR II SYSTEM 999-3322SYS manufactured by Fxi.
| Report Number | 3009402404-2019-00062 |
| MDR Report Key | 9135122 |
| Date Received | 2019-09-30 |
| Date of Report | 2019-09-30 |
| Date of Event | 2019-08-21 |
| Date Mfgr Received | 2019-09-06 |
| Date Added to Maude | 2019-09-30 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | FXI |
| Manufacturer Street | 1032 N 4TH ST. |
| Manufacturer City | BALDWYN MS 38824 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKER AIR II SYSTEM |
| Generic Name | PATIENT AIR MATTRESS |
| Product Code | FNM |
| Date Received | 2019-09-30 |
| Model Number | 999-3322SYS |
| Catalog Number | 999-3322SYS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FXI |
| Manufacturer Address | 1032 N 4TH ST. BALDWYN MS 38824 US 38824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-30 |