MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-06-06 for ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY 06679072001 manufactured by Ventana Medical Systems, Inc.
| Report Number | 2028492-2019-00009 |
| MDR Report Key | 8674703 |
| Report Source | FOREIGN |
| Date Received | 2019-06-06 |
| Date of Report | 2019-07-01 |
| Date of Event | 2019-05-09 |
| Date Mfgr Received | 2019-05-09 |
| Date Added to Maude | 2019-06-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1910 E INNOVATION PARK DRIVE NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY |
| Generic Name | IMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY, ANAPLASTIC LYMPHOMA KINASE |
| Product Code | PKW |
| Date Received | 2019-06-06 |
| Model Number | NA |
| Catalog Number | 06679072001 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC |
| Manufacturer Address | 1910 E INNOVATION PARK DR NA TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-06 |