MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-01-06 for THINPREP IMAGING SYSTEM manufactured by Hologic, Inc..
[17693043]
Potential false negatives. Customer reported they found missed cases; ascus was originally called negative. The missed cases were discovered when there was a concurrent biopsy of adenocarcinoma in one case and an abnormal cervix in the other. Hologic is investigating this complaint and will submit a supplemental mdr to fda when more info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00003 |
| MDR Report Key | 4456991 |
| Report Source | 99 |
| Date Received | 2015-01-06 |
| Date of Report | 2014-12-12 |
| Date Added to Maude | 2015-01-28 |
| 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 | CHRISTINA PAUL |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638912 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | IMAGER |
| Product Code | MNM |
| Date Received | 2015-01-06 |
| 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 | 2015-01-06 |