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 2019-10-23 for 88-SERIES 88-5 manufactured by Getinge Disinfection Ab.
| Report Number | 9616031-2019-00031 |
| MDR Report Key | 9223706 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-23 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-10-21 |
| Device Manufacturer Date | 2014-10-14 |
| Date Added to Maude | 2019-10-23 |
| 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 | LJUNGADALSGATAN 11 |
| Manufacturer City | VAXJO |
| Manufacturer Country | US |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 |
| Manufacturer City | VAXJO |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 88-SERIES |
| Generic Name | DISINFECTOR, MEDICAL DEVICES |
| Product Code | MEC |
| Date Received | 2019-10-23 |
| Model Number | 88-5 |
| 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 | 2019-10-23 |