MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-15 for SURESOUND NS2013KIT manufactured by Hologic, Inc..
[138970448]
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138970449]
It was reported that during a novasure endometrial ablation the suresound device was used and it was noted that pieces from "the plastic part that deploys and expands at os" had broken off in the uterine cavity. The pieces were retrieved and the cavity was clear on hysteroscopy. The ablation was completed successfully with no injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2019-00054 |
| MDR Report Key | 8425339 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2019-03-15 |
| 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 | 2019-03-15 |
| Model Number | NS2013KIT |
| Catalog Number | NS2013KIT |
| Lot Number | 18M03RC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-15 |