MAUDE Adverse Event Report: INMODE LTD MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a rather intense immune-mediated reaction which could be linked to the previous use of lidocaine and tetracaine of which some cases have been reported.It is equally possible that the trigger was a different substance such as aquaphor or another substance used by the patient after the treatment.Obviously, the simultaneous association of several chemical ingredients and the application of fractional rf cannot be excluded as a contributing cause.Investigation conclusions: dx, hyperinflammatory reaction after morpheus8 treatment, reason unknown.Possible topical irritants post-treatment and unknown metal sensitivity.Recommended allergy testing.Did use medrol dose pack and switched to prednisone orally and used topical cortisone and cetaphil.Patient has completely recovered at this point and is asking for second treatment to go on as planned.Provider has declined to treat her again.
Event or Problem Description
Severe allergic reaction over face and decollete in post treatment phase.
Event or Problem Description
Severe allergic reaction over face and decollete in post treatment phase.
Additional Manufacturer Narrative
Follow up report 07/05/2023.1.H6 health effect - impact code - changed to 4619.H11 attached: upon arrival test.Final test.In service report - retrain summary.

• 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: 16386209
• Report Number: 3010511300-2023-00176
• Device Sequence Number: 20257460
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White