MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A; A609126A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Hyperpigmentation (4837)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pie and pih on forehead and abdomen 1 year post morpheu8 tx for face, and 10-11 months post morpheus8 tx for abdomen.
Additional Manufacturer Narrative
Female patient presents with pie and pih on her forehead and abdomen 1 year and 11 months post morpheus8 tx, respectively.Investigation is ongoing.
Event or Problem Description
Pie and pih on forehead and abdomen 1 year post morpheu8 tx for face, and 10-11 months post morpheus8 tx for abdomen.
Additional Manufacturer Narrative
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.
Event or Problem Description
Pie and pih on forehead and abdomen 1 year post morpheu8 tx for face, and 10-11 months post morpheus8 tx for abdomen.
Additional Manufacturer Narrative
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.

• 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: 20245294
• Report Number: 3010511300-2024-00628
• Device Sequence Number: 12583492
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection,Other,Patient Monitoring,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2025

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; A609126A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 08/20/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/07/2024; 03/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 49 YR
• Patient Sex: Female
• Patient Race: Asian