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 2018-11-08 for SURESOUND NS2013KIT manufactured by Hologic, Inc..
[126638470]
The device is not being 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126638471]
It was reported that during an attempted novasure endometrial ablation the physician "had a difficult time dilating the patient and couldn't find the tract. " the procedure was aborted due to a suspected perforation. The novasure device was not inserted into the uterus, but the suresound device was utilized. The perforation was not confirmed. No additional information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2018-00234 |
| MDR Report Key | 8052898 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-08 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-12 |
| Device Manufacturer Date | 2017-10-31 |
| Date Added to Maude | 2018-11-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| 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 | 2018-11-08 |
| Model Number | NS2013KIT |
| Catalog Number | NS2013KIT |
| Lot Number | 17K31RA |
| Device Expiration Date | 2019-11-30 |
| 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 | 1. Other | 2018-11-08 |