FDA Adverse Event
Other
Summary report: N
THE IMAGER
MDR report key: 2310379
·
Received October 23, 2011
Report
- Report Number
- MW5022819
- Event Type
- Other
- Date Received
- October 23, 2011
- Report Date
- October 23, 2011
- Manufacturer
- HOLOGIC CORPORATION
- Product Code
- MKQ
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
HOLOGIC IMAGER MISSED CLUSTER OF DYSPLASIA ON PAP TEST. THIS CYTOTECH, SUPERVISORS AND CO-WORKERS DID NOT BELIEVE TRIGGER CELLS WERE PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE IMAGER | IMAGER | MKQ | HOLOGIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other | THE IMAGER |