FDA Adverse Event
Injury
Summary report: N
MORPHEUS8
MDR report key: 21676261
·
Received March 24, 2025
Report
- Report Number
- 3010511300-2025-00785
- Event Type
- Injury
- Date Received
- March 24, 2025
- Date of Event
- December 22, 2023
- Report Date
- March 24, 2025
- Manufacturer
- INMODE LTD.
- Product Code
- GEI
- UDI-DI
- 07290016633672
- PMA / PMN Number
- K231790
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS INSPECTED AND NO TECHNICAL ISSUES WERE IDENTIFIED. THE TREATMENT WAS PERFORMED ACCORDING TO THE RECOMMENDED PROTOCOL. THE PROLONGED PIH IS MOST PROBABLY ASSOCIATED WITH INITIAL INTENSE INFLAMMATORY REACTION TO THE NUMBING CREAM AND DUE TO PATIENT'S INDIVIDUAL PREDISPOSITION (HIGH FITZPATRICK SKIN TYPE).
Description of Event or Problem · 0
PIH ON LOWER ABDOMEN 1 YEAR AND 3 MONTHS POST MORPHEUS8 TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482142 | MORPHEUS8 | GEI | GEI | INMODE LTD. | AG609126A | 07290016633672 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Other |