MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG609126A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Prolonged intense pie in the abdominal area after one treatment with m8 at 6 months after treatment.Since the pie is observed 6 months post treatment and has exceeded the expected time for full resolution, it was decided to report this incident.Nevertheless, this post-inflammatory erythematous reaction is of a superficial nature and is expected to subside, although currently it is hard to predict the exact time required for the normalization.
Additional Manufacturer Narrative
Adverse event reported 6 months after treatment.During the following period after the ae, the technology has continued to be used regularly and daily without ever having had a problem and therefore a technical inspection at this point could not detect any significant evidence relating to the event that occurred 6 months ago.We suspect either a certain hypersensitivity of the patient or an incorrect setting of parameters used during the treatment.Investigation is in progress.
Event or Problem Description
Prolonged intense pie in the abdominal area after one treatment with m8 at 6 months after treatment.
Additional Manufacturer Narrative
On 06-sep-2023: fu report is submitted to update/correct the following fields: b5 (event description) was updated; d7a - 'no' was ticked; d9 - date returned to manufacturer was added; h3 - was updated to 'yes'; h6 - codes were updated as follows: type of investigation 'testing of actual/suspected device' was added, investigation findings were updated to 'no device problem found', investigation conclusions were updated to 'caused traced to non-device related factors'.H7 - 'inspection' was added; service inspection reports have been attached.Investigation summary: the immediate immune reaction was most probably triggered by using a numbing cream with high percentage of anesthetics and individual factors.Further, the healing was impeded due to peripheral treatment area.Service inspection revealed no technical issues and treatment parameters are in accordance with the recommendations in ifu.Importantly, there is a remarkable improvement in skin laxity of the abdomen on the "6 months post treatment" photos relative to before photos provided to inmode.The patient is not responsive to clinic's attempts to reach her to get more recent photos.Hence, the case was closed.

• 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: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 17255608
• Report Number: 3010511300-2023-00299
• Device Sequence Number: 15424344
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192695
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: AG609126A
• Device Catalogue Number: AG609126A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: 24 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White