FDA Adverse Event
Death
Summary report: N
POWER MORCELLATOR INVOLVED IN MORCELLATION
MDR report key: 6348650
·
Received February 20, 2017
Report
- Report Number
- MW5067976
- Event Type
- Death
- Date Received
- February 20, 2017
- Date of Event
- March 8, 2012
- Report Date
- February 20, 2017
- Manufacturer
- UNK
- Product Code
- HET
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
DURING A HYSTERECTOMY, MY SISTER UNDERWENT A LAPAROSCOPIC REMOVAL OF HER UTERUS VIA MORCELLATION AS A MINIMALLY INVASIVE OPERATION. THE RESULTS OF THE LAB WORK SHOWED THE TISSUE TO BE CANCEROUS WHICH MEANT THOSE CELLS HAD BEEN "SCATTERED" THROUGHOUT HER ABDOMINAL CAVITY. THREE YEARS OF ADDITIONAL OPERATIONS, CHEMOTHERAPY, RADIATION, AND SUFFERING FOLLOWED AND ENDED WITH HER DEATH ON (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126469 | POWER MORCELLATOR INVOLVED IN MORCELLATION | LAPAROSCOPE GYNECOLOGIC | HET | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Death| H| L| S |