MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-11-25 for CRYOMACS FREEZING BAGS 750 N/A 200-074-403 manufactured by Miltenyi Biotec B.v. & Co. Kg.
| Report Number | 3005290010-2019-00006 |
| MDR Report Key | 9370529 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-25 |
| Date Mfgr Received | 2019-10-30 |
| Date Added to Maude | 2019-11-25 |
| 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 | DR. BETTINA-JUDITH H |
| Manufacturer Street | FRIEDRICH-EBERT-STR. 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal | 51429 |
| Manufacturer G1 | MILTENYI BIOTEC B.V. & CO. KG |
| Manufacturer Street | FRIEDRICH-EBERT-STR. 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOMACS FREEZING BAGS 750 |
| Generic Name | CRYOMACS FREEZING BAGS 750 |
| Product Code | KSR |
| Date Received | 2019-11-25 |
| Model Number | N/A |
| Catalog Number | 200-074-403 |
| Lot Number | 6190220015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC B.V. & CO. KG |
| Manufacturer Address | FRIEDRICH-EBERT-STR. 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-25 |