MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for REAGENT RED BLOOD CELLS BIOTESTCELL-I11 816021100 manufactured by Bio-rad Medical Diagnostics Gmbh.
| Report Number | 9610824-2019-00056 |
| MDR Report Key | 9178405 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-11 |
| Date of Event | 2019-09-04 |
| Date Mfgr Received | 2019-09-12 |
| Date Added to Maude | 2019-10-11 |
| 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 MARTINA BENKERT |
| Manufacturer Street | INDUSTRIESTRASSE 1 |
| Manufacturer City | DREIEICH, HESSEN 63303 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63303 |
| Manufacturer G1 | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Manufacturer Street | INDUSTRIESTRASSE 1 |
| Manufacturer City | DREIEICH, 63303 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 63303 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REAGENT RED BLOOD CELLS BIOTESTCELL-I11 |
| Generic Name | BIOTESTCELL-I11 |
| Product Code | KSZ |
| Date Received | 2019-10-11 |
| Catalog Number | 816021100 |
| Lot Number | 8929011-00 |
| Device Expiration Date | 2019-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 1 DREIEICH, 63303 GM 63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |