MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-02 for ORTHO PROVUE MTS213784 manufactured by Microtyping Systems.
| Report Number | 1056600-2020-00005 |
| MDR Report Key | 9775858 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2020-03-02 |
| 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 | MR. JAMES A STEVENS |
| Manufacturer Street | 1001 ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082188223 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO PROVUE |
| Generic Name | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM |
| Product Code | KSZ |
| Date Received | 2020-03-02 |
| Catalog Number | MTS213784 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTYPING SYSTEMS |
| Manufacturer Address | 1295 SOUTHWEST 29TH AVENUE POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |