MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for POWER MORCELLATOR manufactured by .
[78472172]
In (b)(6) 2007, i had a laparoscopic myomectomy which turned into a hysterectomy during the surgery. A power morcellator was used during the procedure. In (b)(6), i developed a lump underneath the left laparoscopic port site. I was told by drs that it was likely a lipoma and nothing to worry about. Because the lump seemed to be getting bigger, in (b)(6) 2015, i urged my dr to test it. We did a routine ct scan in (b)(6) 2016 and a biopsy in (b)(6) 2016. In (b)(6) 2016, it was determined that i had leiomyosarcoma. From (b)(6) to (b)(6), i underwent treatment for stage iiib or stage iv leiomyosarcoma (tumor was 8cm), including six rounds of chemotherapy, 28+ radiation treatment, and major surgery to remove the tumor. Thankfully, we got clear margins during surgery. I think the stage is now iiib because the secondary sites in my lungs do not seem to be growing and are too small to biopsy at this moment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070620 |
| MDR Report Key | 6666818 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2007-08-14 |
| Date Added to Maude | 2017-06-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | POWER MORCELLATOR |
| Generic Name | POWER MORCELLATOR |
| Product Code | HET |
| Date Received | 2017-06-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | POWER MORCELLATOR |
| Generic Name | POWER MORCELLATOR |
| Product Code | PTE |
| Date Received | 2017-06-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit | 2017-06-22 |