MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypopigmentation (4838)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In addition to the report made by the clinic to our call center, the patient herself made a voluntary report to the fda number mw5117220 dated april 28 (attached next).
Event or Problem Description
Multiple hypopigmented lesions of variable shape (rounded and linear) located in the submental and neck area following a treatment with m8 performed about a month ago.Rectangular erythematous areas (tip footprints) can also be seen in the lateral and medial aspect of the neck.Although sometimes, in cases of individual hypersensitivity, the skin reaction requires a few weeks for the texture to normalize; such early appearance of hypopigmented lesions could be considered rather anomalous and unexpected for which the recovery time could have a longer duration, currently unknown.
Additional Manufacturer Narrative
(b)(6)2023: follow up report is submitted to update/correct the following: b5 - event description was updated.B7 - medical history was updated.D9 - was corrected to 'no'.G2 - was corrected.H3 - was updated.H6 - codes were updated.H7 - updated.Investigation concluded that the root cause can be attributed to several factors: the reaction appears as individual hypersensitivity reaction, exacerbated by a numbing cream with high percentage of anesthetics and aggressive treatment parameters (extra pass at 1mm depth with high energy settings).In addition, patch test was not performed contrary to ifu, which is extremely important in a patient with a known allergy history.The customer declined technical inspection of the device and was irresponsive to inmode's attempts to schedule a retraining.The clinic updated inmode that the patient is doing well, the spots had continually been fading and per latest update, only one spot is left and it is barely visible.
Event or Problem Description
Hypopigmented lesions in the submental and neck area, about 1 month post morpheus8 treatment, and erythematous areas (tip footprints) in the lateral and medial aspect of the neck.In addition to the report made by the clinic to inmode's call center, the patient herself made a voluntary report to the fda (mw5117220) dated april 28, complaining about "swelling, pain, and itching and still had redness a month later".

• 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: 16928239
• Report Number: 3010511300-2023-00257
• Device Sequence Number: 12495210
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/14/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White