MORPHEUS8
Report
- Report Number
- 3010511300-2024-00628
- Event Type
- Injury
- Date Received
- September 18, 2024
- Date of Event
- September 28, 2023
- Report Date
- March 2, 2025
- Manufacturer
- INMODE LTD.
- Product Code
- GEI
- UDI-DI
- 07290016633412
- PMA / PMN Number
- K200947
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FEMALE PATIENT PRESENTS WITH PIE AND PIH ON HER FOREHEAD AND ABDOMEN 1 YEAR AND ~11 MONTHS POST MORPHEUS8 TX, RESPECTIVELY. INVESTIGATION IS ONGOING. 07-OCT-2024: FOLLOW UP REPORT IS SUBMITTED WITH INVESTIGATION CONCLUSIONS. THE CUSTOMER AGREED TO INSPECT ONLY ONE OF THE APPLICATORS AND NO TECHNICAL ISSUES WERE FOUND. BUT SINCE THE TREATMENT WAS DONE A YEAR AGO AND NO COMPLAINTS WERE RECEIVED FROM THIS CUSTOMER SINCE THEN, IT IS REASONABLE TO ASSUME NO TECHNICAL ISSUES EXIST WITH THE PLATFORM NOR THE SECOND APPLICATOR. THE CUSTOMER BECAME NON-RESPONSIVE AND DID NOT FILL THE CLINICAL FORM, NOR DID THEY RESPOND TO INMODE'S ATTEMPTS TO SCHEDULE A RETRAINING. DUE TO LACK OF COOPERATION ON CUSTOMER'S SIDE AND INSUFFICIENT INFORMATION THE ROOT CAUSE COULD NOT BE ESTABLISHED.
FEMALE PATIENT PRESENTS WITH PIE AND PIH ON HER FOREHEAD AND ABDOMEN 1 YEAR AND 11 MONTHS POST MORPHEUS8 TX, RESPECTIVELY. INVESTIGATION IS ONGOING.
FEMALE PATIENT PRESENTS WITH PIE AND PIH ON HER FOREHEAD AND ABDOMEN 1 YEAR AND ~11 MONTHS POST MORPHEUS8 TX, RESPECTIVELY. INVESTIGATION IS ONGOING. 07-OCT-2024: FOLLOW UP REPORT IS SUBMITTED WITH INVESGATION CONCLUSIONS. THE CUSTOMER AGREED TO INSPECT ONLY ONE OF THE APPLICATORS AND NO TECHNICAL ISSUES WERE FOUND. BUT SINCE THE TREATMENT WAS DONE A YEAR AGO AND NO COMPLAINTS WERE RECEIVED FROM THIS CUSTOMER SINCE THEN, IT IS REASONABLE TO ASSUME NO TECHNICAL ISSUES EXIST WITH THE PLATFORM NOR THE SECOND APPLICATOR. THE CUSTOMER BECAME NON-RESPONSIVE AND DID NOT FILL THE CLINICAL FORM, NOR DID THEY RESPOND TO INMODE'S ATTEMPTS TO SCHEDULE A RETRAINING. DUE TO LACK OF COOPERATION ON CUSTOMER'S SIDE AND INSUFFICIENT INFORMATION THE ROOT CAUSE COULD NOT BE ESTABLISHED. 02-MAR-2025: ADDITIONAL INFORMATION WAS RECEIVED FROM THE TREATMENT PROVIDER. THE RECENT PHOTOS PRESENT IMPROVEMENT OF THE REPORTED CONDITION. TREATMENT SETTINGS WERE CONGRUENT WITH THE RECOMMENDED PROTOCOL. HOWEVER, THE PATIENT STARTED TO APPLY IRRITATIVE SUBSTANCES (HYDROQUINONE AND RETINOL) LESS THAN 1 MONTH POST MORPHEUS8 PROCEDURE ON THE SKIN THAT HASN'T FULLY HEALED, ASSUMING INITIAL INTENSE INFLAMMATORY REACTION DUE TO PATIENT'S INDIVIDUAL PREDISPOSITION (OR REACTION TO THE 23/7 NUMBING CREAM). THE SUBSTANCES HAVE BEEN APPLIED INTERMITTENTLY FOR 1 YEAR AND 4 MONTHS, WHICH CONTRIBUTED TO THE INFLAMMATORY PROCESS, FURTHER DELAYED THE HEALING AND LED TO THE REPORTED PIE/PIH. THE CLINIC RECEIVED GUIDANCE FROM INMODE WITH REGARDS TO THESE CONCLUSIONS.
PIE AND PIH ON FOREHEAD AND ABDOMEN 1 YEAR POST MORPHEU8 TX FOR FACE, AND 10-11 MONTHS POST MORPHEUS8 TX FOR ABDOMEN.
PIE AND PIH ON FOREHEAD AND ABDOMEN 1 YEAR POST MORPHEU8 TX FOR FACE, AND 10-11 MONTHS POST MORPHEUS8 TX FOR ABDOMEN.
PIE AND PIH ON FOREHEAD AND ABDOMEN 1 YEAR POST MORPHEU8 TX FOR FACE, AND 10-11 MONTHS POST MORPHEUS8 TX FOR ABDOMEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1384476 | MORPHEUS8 | GEI | GEI | INMODE LTD. | AG607401A; A609126A | 07290016633412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Other |