MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-24 for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS 1286293 manufactured by Ortho-clinical Diagnostics.
| Report Number | 3007111389-2019-00168 |
| MDR Report Key | 9235193 |
| Date Received | 2019-10-24 |
| Date of Report | 2019-10-24 |
| Date of Event | 2019-09-28 |
| Date Mfgr Received | 2019-09-29 |
| Device Manufacturer Date | 2019-01-08 |
| Date Added to Maude | 2019-10-24 |
| 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 | FELINDRE MEADOWS PENCOED |
| Manufacturer City | BRIDGEND, WALES CF355PZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF35 5PZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | JIS |
| Date Received | 2019-10-24 |
| Catalog Number | 1286293 |
| Lot Number | 2510 |
| Device Expiration Date | 2019-10-18 |
| 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 | 2019-10-24 |