MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-03 for TYPHOON SP6000AR009-FR manufactured by Getinge Disinfection Ab.
| Report Number | 3007420694-2019-00089 |
| MDR Report Key | 8661886 |
| Date Received | 2019-06-03 |
| Date of Report | 2019-06-28 |
| Date Facility Aware | 2019-05-21 |
| Report Date | 2019-06-28 |
| Date Reported to FDA | 2019-06-28 |
| Date Reported to Mfgr | 2019-06-28 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2010-10-18 |
| Date Added to Maude | 2019-06-03 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 |
| Manufacturer City | VAXJO, VAXJO KRONOBERGS IAN [SE-07] 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TYPHOON |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2019-06-03 |
| Model Number | SP6000AR009-FR |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO, VAXJO KRONOBERGS IAN [SE-07] 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-03 |