MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-06 for ANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML 760-2135 05266840001 manufactured by Ventana Medical Systems, Inc..
[18071354]
Patient tissue tested at clinic was initially reported as negative, however, upon consult with another facility tissue reported positive.
Patient Sequence No: 1, Text Type: D, B5
[18550454]
Requests for additional information and discussions with pathologist at clinic are ongoing. No reports of impact to patient care at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028492-2015-00002 |
| MDR Report Key | 4584985 |
| Report Source | 05,06 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-05 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2015-02-05 |
| Date Added to Maude | 2015-03-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR. |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML |
| Generic Name | PAN CK |
| Product Code | NJT |
| Date Received | 2015-03-06 |
| Model Number | 760-2135 |
| Catalog Number | 05266840001 |
| Lot Number | UNK |
| ID Number | 04015630971572 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-06 |