MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-04 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UNKNOWN manufactured by Hologic, Inc.
[178017838]
Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[178017839]
This is the second of two hologic reports related to this event. Please also refer to 1222780-2020-00021 for the first report. It was reported to hologic by the performing physician that in october or (b)(6) of 2019, he had completed an uncomplicated fibroid removal procedure followed by an endometrial ablation. Both procedures were completed without incident. The physician stated "the patient went home with some discomfort however later on in the evening the patient was not feeling well. " he suggested the patient go to the emergency department. The patient arrived that night at 1:00am and had blood work done with culture. The culture results were positive for strep and sepsis. The patient was monitored and prescribed medication. The patient had a laparoscopic procedure three days later to rule out any puss or infection in the abdomen. "there were no findings of infection in the abdomen and all looked benign. " a hysteroscopy was also performed and there was no signs of any puss or fluid build up in the uterine cavity. The physician stated the patient is doing very well and no signs of infection to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00022 |
| MDR Report Key | 9663284 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-04 |
| 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 | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082636130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVASURE IMPEDANCE CONTROLLED EA SYSTEM |
| Generic Name | UTERINE ABLATION DEVICE |
| Product Code | MNB |
| Date Received | 2020-02-04 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-02-04 |