MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for NOVASURE ADVANCED SURESOUND NS2013KITUS manufactured by Hologic, Inc..
[110648708]
Patient Sequence No: 1, Text Type: N, H10
[110648710]
Novasure would not pass the cavity assessment, it kept failing. A second device was opened and functioned as expected. Manufacturer response for impedence controlled endometrial ablation disposable, novasure advanced suresound (per site reporter) : manufacturer provided rga# and product return packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7586344 |
| MDR Report Key | 7586344 |
| Date Received | 2018-06-11 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-04-25 |
| Report Date | 2018-05-29 |
| Date Reported to FDA | 2018-05-29 |
| Date Reported to Mfgr | 2018-05-29 |
| Date Added to Maude | 2018-06-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVASURE ADVANCED SURESOUND |
| Generic Name | SOUND, UTERINE |
| Product Code | HHM |
| Date Received | 2018-06-11 |
| Returned To Mfg | 2018-05-11 |
| Catalog Number | NS2013KITUS |
| Lot Number | 18A09RD |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-11 |