FDA Adverse Event
Death
Summary report: N
MORPHEUS8
MDR report key: 23496617
·
Received November 7, 2025
Report
- Report Number
- MW5178594
- Event Type
- Death
- Date Received
- November 7, 2025
- Date of Event
- March 21, 2025
- Report Date
- November 4, 2025
- Manufacturer
- INMODE LTD.
- Product Code
- GEI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
MICRONEEDLING WAS PERFORMED ON MY SISTER, (B)(6), IN MEXICO, AND SHE DIED DURING THE PROCEDURE ON (B)(6) 2025. I CAN BE REACHED VIA EMAIL AT (B)(6) AND VIA MY MOBILE NUMBER (B)(6) AS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1808227 | MORPHEUS8 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | INMODE LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Death |