N
Patient 1
MAUDE MDR 5766760
- MDR report key
- 5766760
- Report number
- 2183608-2016-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-06-09
- Date received
- 2016-07-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. PADMINI SAHOO
- Address
- 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US
- Phone
- 262-262-2627
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PF4 IGG | PF4 IGG | IMMUCOR GTI DIAGNOSTICS, INC. | LCO | NA | HAT45G | 3003584 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-07-01 | 0 |
Event Narratives#
D
Patient 1
CUSTOMER COMPLAINT (PR # (B)(4)) RECEIVED ON 06-10-2016, WHERE CUSTOMER INFORMED ABOUT UNEXPECTED NEGATIVE RESULTS WITH PF4 IGG ASSAY (HAT45G) LOT 3003584 FOR ASSAY RUN ON (B)(6) 2016.
N
Patient 1