MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-31 for 86-SERIES 8668 S-86682003-CTOM manufactured by Getinge Disinfection Ab.
| Report Number | 9616031-2019-00041 |
| MDR Report Key | 9535799 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-31 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2019-12-31 |
| 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. PASCAL JAY |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET SAS |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 86-SERIES |
| Generic Name | DISINFECTOR, MEDICAL DEVICES |
| Product Code | MEC |
| Date Received | 2019-12-31 |
| Model Number | 8668 |
| Catalog Number | S-86682003-CTOM |
| 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 DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-31 |