MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-13 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM NS2013 manufactured by Hologic, Inc.
[175056519]
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. 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. 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 or the radio frequency controller as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[175056520]
A hologic representative was informed that 20 days post endometrial ablation procedure, the patient presented with severe abdominal. A ct scan suggested possible intra abdominal pathology. A laparoscopy was performed and it was noted that the left fallopian tube was grossly thickened and attached to the lateral pelvic wall. "the round ligament was oedematous and there was some purulent material present. Presumptive diagnosis of hydrosalpinx and localise collection was made. " it was decided to remove the fallopian tube, as the patient was unresponsive to iv antibiotics. "suction, irrigation was done followed by a drain placement to the left iliac fossa port. Continued on iv antibiotics post op, drain removed in 24hrs. Specimens sent for histology included endometrial curette, fallopian tube and vaginal fluid for microbiology. Cultures from pelvic fluid grew proteus mirabiliscillus & blood cultures grew gram positive rods of paenibacillus provencensis. " patient was discharged home. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00009 |
| MDR Report Key | 9584453 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Model Number | NS2013 |
| Catalog Number | NS2013 |
| 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. Required No Informationntervention; 3. Deathisabilit | 2020-01-13 |