MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for HEMOCCULT II SENSA 64151 manufactured by Beckman Coulter, Inc..
[38537656]
Patient Sequence No: 1, Text Type: N, H10
[38537657]
Each card has a control window and i am told that the positive control window should be white with no obvious color. However, all of these (several boxes) have a grey/blue ink mark in the control window.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5446462 |
| MDR Report Key | 5446462 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-15 |
| Date of Event | 2016-01-27 |
| Report Date | 2016-02-15 |
| Date Reported to FDA | 2016-02-15 |
| Date Reported to Mfgr | 2016-02-15 |
| Date Added to Maude | 2016-02-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCCULT II SENSA |
| Generic Name | REAGENT, OCCULT BLOOD |
| Product Code | KHE |
| Date Received | 2016-02-19 |
| Model Number | 64151 |
| Lot Number | 52251 13R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 740 WEST 83RD ST. HIALEAH FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |