D
Patient 1
STOOL FOR OCCULT BLOOD SENT; LAB CALLED AND SAID THERE WAS SOMETHING WRONG WITH THE SPECIMEN CARDS. THEY ARE LIGHT BLUE IN COLOR TO START BEFORE THE TESTING WAS DONE, AND BLUE IS A POSITIVE TEST.
MAUDE MDR 8018794
- MDR report key
- 8018794
- Report number
- 8018794
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-08-15
- Date received
- 2018-10-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HEMOCCULT | REAGENT, OCCULT BLOOD | BECKMAN COULTER, INC. | KHE | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-30 | 0 |