MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-08-07 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc.
[3608717]
Possible diagnostic cells outside field of view. No triggers were found. One group of 6 lsil cells found on the slide during routine qc. Rare lsil cells, clean background with some inflammation was on slide. Customer will continue to hold cases for future cytology application support specialist visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00148 |
| MDR Report Key | 3289970 |
| Report Source | 00 |
| Date Received | 2013-08-07 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-07-30 |
| Date Added to Maude | 2013-08-28 |
| 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, MGR RA |
| 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 | AUTOMATED MICORSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2013-08-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-08-07 |