MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-24 for VITROS CHEMISTRY PRODUCTS K+ SLIDES 8157596 manufactured by Ortho-clinical Diagnostics.
| Report Number | 1319809-2019-00044 |
| MDR Report Key | 8727222 |
| Date Received | 2019-06-24 |
| Date of Report | 2019-06-24 |
| Date of Event | 2019-05-23 |
| Date Mfgr Received | 2019-05-26 |
| Device Manufacturer Date | 2019-04-04 |
| Date Added to Maude | 2019-06-24 |
| 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 | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS K+ SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | CEM |
| Date Received | 2019-06-24 |
| Catalog Number | 8157596 |
| Lot Number | 4102-1013-8371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-24 |