MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for ROLLERBALL ABLATION-NOVA SURE manufactured by Hologic, Inc..
[178208640]
I got patss (b)(6) 2019 after an endometrial ablation back in 2016. I had been previously sterilised and was both made aware that ablation can cause major issues. I suffered labour like pains, admitted to hospital for pain management. I also had a lump in my womb and due to the ablation they were unable to biopsy this. This meant i had no other choice but to have a hysterectomy in (b)(6) 2019. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092789 |
| MDR Report Key | 9676759 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-01-04 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROLLERBALL ABLATION-NOVA SURE |
| Generic Name | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
| Product Code | MNB |
| Date Received | 2020-02-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-02-05 |