MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-06 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM manufactured by Hologic, Inc.
[178637654]
Limited initial reporter information available due to the nature of the complaint. Lot and model 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
[178637655]
An email was received from a patient on january 13th 2020, complaining of post-ablation pain. The patient reportedly had an endometrial ablation done in (b)(6) 2019 and is experiencing pain which is progressively getting worse, "it's almost what i imagine a taste labour pains would be like" and her "ovaries feel like they're being twisted and burning. " patient has discussed hysterectomy with her provider but states she is not ready to consider this an option. Patient has seen multiple doctors and been "re-referred. " no additional details available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00025 |
| MDR Report Key | 9679507 |
| Report Source | OTHER |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| 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. Other | 2020-02-06 |