MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-21 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc..
[3255800]
Potential false negative. Abnormal cells outside 22 fields of view. Abnormal cells were discovered by the lab during qc. Site will be monitored to determine if expected occurrences (as determined by the pivotal study) are exceeded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00062 |
| MDR Report Key | 3020629 |
| Report Source | 05 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-02-22 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-02-22 |
| Date Added to Maude | 2013-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDALL COVILL, MANAGER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638853 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | IMAGER |
| Product Code | MNM |
| Date Received | 2013-03-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC. |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-21 |