MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-07-10 for 500-SERIES 522HC-E manufactured by Getinge Ic Production Poland Sp. Z O.o..
| Report Number | 3012068831-2019-00005 |
| MDR Report Key | 8774950 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-07-10 |
| Date of Report | 2019-11-08 |
| Date Mfgr Received | 2019-06-25 |
| Date Added to Maude | 2019-07-10 |
| 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 | MR. DENNIS GENITO |
| Manufacturer Street | SZKOLNA 30 |
| Manufacturer City | PLEWISKA WIELKOPOLSKIE |
| Manufacturer Country | US |
| Manufacturer G1 | GETINGE IC PRODUCTION POLAND SP. Z O.O. |
| Manufacturer Street | SZKOLNA 30 |
| Manufacturer City | PLEWISKA WIELKOPOLSKIE |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 500-SERIES |
| Generic Name | STERILIZER, STEAM |
| Product Code | FLE |
| Date Received | 2019-07-10 |
| Model Number | 522HC-E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE IC PRODUCTION POLAND SP. Z O.O. |
| Manufacturer Address | SZKOLNA 30 PLEWISKA WIELKOPOLSKIE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-10 |