MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-30 for HETTICH ROTANTA 460 R 5605 manufactured by Andreas Hettich Gmbh & Co. Kg.
| Report Number | 3005990076-2020-00001 |
| MDR Report Key | 9648025 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-07-04 |
| Date Mfgr Received | 2019-07-08 |
| Device Manufacturer Date | 2002-08-12 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHANN GIEBELHAUS |
| Manufacturer Street | FOEHRENSTR. 12 |
| Manufacturer City | TUTTLINGEN, BADEN-W 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | ANDREAS HETTICH GMBH & CO. KG |
| Manufacturer Street | FOEHRENSTR. 12 |
| Manufacturer City | TUTTLINGEN, BADEN-W 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HETTICH |
| Generic Name | ROTANTA 460 R |
| Product Code | JQC |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2019-07-09 |
| Model Number | ROTANTA 460 R |
| Catalog Number | 5605 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 17 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANDREAS HETTICH GMBH & CO. KG |
| Manufacturer Address | FOHRENSTR. 12 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |