MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-25 for HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY 790-2991 manufactured by Ventana Medical Systems, Inc..
[2872459]
The customer called to report dispenser lot #680957 of pathway her2 (4b5) is staining lighter than expected. No report of pt harm or pt care being adversely affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2009-00001 |
| MDR Report Key | 2651332 |
| Report Source | 05,06 |
| Date Received | 2009-09-25 |
| Date of Report | 2009-08-17 |
| Date of Event | 2009-08-17 |
| Date Mfgr Received | 2009-08-17 |
| Date Added to Maude | 2012-07-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TWEED HANUSEK |
| Manufacturer Street | 1910 E. INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5202294130 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY |
| Generic Name | PATHWAY HER2 (4B5) |
| Product Code | MVC |
| Date Received | 2009-09-25 |
| Returned To Mfg | 2009-08-26 |
| Model Number | 790-2991 |
| Catalog Number | 790-2991 |
| Lot Number | 680957 |
| ID Number | NA |
| Device Expiration Date | 2011-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. TUCSON AZ 85755 US 85755 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-25 |