MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-27 for SURESOUND NS2013KIT manufactured by Hologic, Inc..
[140124228]
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. Internal complaint reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140124229]
It was reported that the suresound uterine sounding device was used prior to a novasure endometrial ablation. After the ablation was completed the physician viewed the cavity and noted three pieces that had broken off of the suresound device. The physician was able to successfully removal all three pieces from the uterine cavity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2019-00064 |
| MDR Report Key | 8457442 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2019-03-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESOUND |
| Generic Name | UTERINE SOUNDING DEVICE |
| Product Code | HHM |
| Date Received | 2019-03-27 |
| Model Number | NS2013KIT |
| Catalog Number | NS2013KIT |
| Lot Number | 18M07RC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-27 |