MAUDE Adverse Event Report: INMODE LTD MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Papular lesions in the shape of the tip footprint in the central region of the forehead and over the neck.Apparently, a reaction of the superficial dermis due to an exuberance of superficially concentrated thermal energy.The healing process delay most probably due to various factors, such as application of cosmetic/medicinal products post treatment and individual intrinsic factors.Since the lesions are still present 5 months post treatment exceeding the expected time for full resolution, it was decided to report this incident.Nevertheless, gradual skin texture normalization is expected within a variable period without permanent fibrotic outcomes or scarring.
Additional Manufacturer Narrative
(b)(6) 2023 - a case of prolonged healing due to predisposing factors such as acne, assumption of isotretinoin as well as use of a intense superficial impacted settings by the user.
Additional Manufacturer Narrative
06-sep-2023: updated information was received from the clinic on 29-aug-2023 regarding patient's healing status, stating "the patient is now doing very well, no sequelas.".Clinic was retrained and retraining report is attached within this follow-up.In addition, the following fields were corrected in this follow-up report: b5 (event description) was updated, d7a was changed to 'no', d7b was removed.
Event or Problem Description
Papular lesions in the shape of the tip footprint in the central region of the forehead and over the neck.

• 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 0; IS 206920
• Manufacturer Contact: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-0 ; IS 206920
• MDR Report Key: 17583494
• Report Number: 3010511300-2023-00276
• Device Sequence Number: 4801980
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Administrator/Supervisor
• Remedial Action: Other,Notification,Patient Monitoring
• 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: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White