MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Impaired Healing (2378); Hyperpigmentation (4837)
Date of Event	09/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinic confirmed it's an isolated incident in their practice and the device works with no issues.Inmode did not receive the clinical form with all the relevant clinical information.The information about the treatment was provided in an inconsistent way (several versions of the treatment settings provided).Patient's medical background is unknown.It seems that the patient initially had a prolonged inflammatory reaction, that could be triggered by intrinsic factors and/or reaction to the numbing cream with high percentage of anesthetics.It's unknown when the clinic started treating the patient with hydroquinone and for how long, which could have also contributed to the reported adverse events.Post-treatment exposure to sun cannot be excluded.Combination of various intrinsic and extrinsic factors seem to have contributed to the reported aes.However, due to inconsistency of information and its partial nature, inmode cannot unequivocally establish the root-cause.
Event or Problem Description
A female patient presenting with pih/pie replicating morpheus8 needle insertion sites on face and upper neck.8 months post treatment.

• Brand Name: MORPHEUS8
• 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: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 25454102
• Report Number: 3010511300-2026-01107
• Device Sequence Number: 15634724
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K200947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White