MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-17 for 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-750 manufactured by Charter Medical, Ltd..
| Report Number | 1066733-2020-00004 |
| MDR Report Key | 9603645 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2020-01-17 |
| 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 | MS. LISA HINSHAW |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 271036770 |
| Manufacturer Country | US |
| Manufacturer Postal | 271036770 |
| Manufacturer Phone | 3367144221 |
| Manufacturer G1 | CHARTER MEDICAL, LTD. |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 271036770 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 271036770 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2020-01-17 |
| Model Number | CF-750 |
| Catalog Number | CF-750 |
| Lot Number | 152297 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHARTER MEDICAL, LTD. |
| Manufacturer Address | 3948-A WESTPOINT BLVD. WINSTON SALEM NC 271036770 US 271036770 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |