D
Patient 1
CUSTOMER REPORTED THAT AN IMMAGE CALIBRATOR REAGENT CONTAINER WAS RECEIVED AT THE WAREHOUSE DAMAGED AND LEAKING. NO INJURIES WERE REPORTED.
MAUDE MDR 2393374
- MDR report key
- 2393374
- Report number
- 2050012-2011-07348
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-06-18
- Date received
- 2011-11-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS NORA ZEROUNIAN
- Address
- 250 SOUTH KRAEMER BLVD. BREA CA 92821 US
- Phone
- 714-714-7149
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMMAGE CAL 1 | BECKMAN COULTER, INC. | DEX | NA | 449560 | M904529 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-11-15 | 0 |
Event Narratives#
N
Patient 1
NO PRODUCT WAS RETURNED FOR EVALUATION; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.