MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-25 for HEMOCUE HB 201+ SYSTEM 121704 manufactured by Hemocue Ab.
| Report Number | 3003044483-2019-00009 |
| MDR Report Key | 8730106 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-06-25 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-06-19 |
| Device Manufacturer Date | 2015-03-16 |
| Date Added to Maude | 2019-06-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MARIA FAGERBERG |
| Manufacturer Street | KUVETTGATAN 1 |
| Manufacturer City | 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal | 26271 |
| Manufacturer G1 | HEMOCUE AB |
| Manufacturer Street | KUVETTGATAN 1 |
| Manufacturer City | 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 26271 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCUE HB 201+ SYSTEM |
| Generic Name | HEMOGLOBIN TEST SYSTEM |
| Product Code | GKR |
| Date Received | 2019-06-25 |
| Returned To Mfg | 2019-06-03 |
| Model Number | 121704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMOCUE AB |
| Manufacturer Address | KUVETTGATAN 1 ?NGELHOLM, 26271 SW 26271 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-25 |