MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for MORCELLATOR manufactured by Unknown.
[137536194]
I had a myomectomy with morcellation for a large fibroid. A bag was not used. I was not trying to maintain my fertility and did not want to have any more children. I was trying to avoid a hysterectomy. My fibroid ended up being leiomyosarcoma. On (b)(6) 2018 a hysterectomy, oophorectomy and cervix removal were performed by a different doctor. No evidence of spread was noted until (b)(6) 2019 when i had a vaginal cuff dehiscence. At that time i went in to surgery, where 30 plus tumors (approx) were found in my pelvis. I had a rectosigmoid resection with anastomosis, tumor debulking, vaginal cuff repair, and ablation. On (b)(6) 2019 another ct was performed and 10 plus tumors were found to be growing. I am set to have chemo (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084509 |
| MDR Report Key | 8378436 |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-09-06 |
| Date Added to Maude | 2019-02-28 |
| 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 | 0 |
| Brand Name | MORCELLATOR |
| Generic Name | LAPAROSCOPE GYNECOLOGIC (AND ACCESSORIES) |
| Product Code | HET |
| Date Received | 2019-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit | 2019-02-27 |