MAUDE Adverse Event Report: INMODE LTD MORPHEUS 8; GEI

Model Number	AG607401A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Erythema (1840); Hyperpigmentation (4837)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initially the patient contacted inmode directly via email, consequently we identified the clinic that provided the service and we received information relating to this the ae (ccq) therefore in addition to the patient details (initial reporter) we hereby report the clinic details as well: (b)(6).Investigation results: user error; too aggressive treatment parameters (83mj/pin) and 3mm on neck, (67 mj/pin) 2mm on forehead.Intervals between treatments were too short which did not allow the skin to recover before next treatment.Photos before 2nd and 3rd treatment show skin that should not undergo treatment due to an incomplete recovery.Post treatment application of aggressive substances that did not enable healing (enzymatic peel, aha serum, hydroquinone, alumier recovery balm).In summary, aggressive treatment parameters, intervals between treatments too short, application of aggressive substances on skin following treatment which did not allow skin recovery.
Event or Problem Description
A widespread post-inflammatory erythematous state over the entire face and neck 7 months after treatment with m8.The footprints in the shape of the tip matrix are observable.Post-inflammatory hyperpigmentation is also visible at the needle insertion points.The clinical picture would appear to be a compromised and altered healing process.According to the updated information received from the patient, the pie reaction has not subsided after 7 months.Due to the longevity of the reaction, it was decided to report this event.
Additional Manufacturer Narrative
08/21/2023.G3 - date received by manufacturer was corrected to 04/19/2023 to reflect the initial awareness date, however, at that moment the skin reaction was assessed as non reportable since contemplated within expected and acceptable side effect.Later on, an update was received by the patient stating prolonged pie/pih and therfore it was decided to report this ae.
Event or Problem Description
A widespread post-inflammatory erythematous state over the entire face and neck 7 months after treatment with m8.The footprints in the shape of the tip matrix are observable.Post-inflammatory hyperpigmentation is also visible at the needle insertion points.The clinical picture would appear to be a compromised and altered healing process.According to the updated information received from the patient, the pie reaction has not subsided after 7 months.Due to the longevity of the reaction, it was decided to report this event.

• Brand Name: MORPHEUS 8
• Common Device Name: GEI
• Manufacturer (Section D): INMODE LTD; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 17379134
• Report Number: 3010511300-2023-00220
• Device Sequence Number: 6083810
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring,Other,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White