MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Granuloma (1876); Skin Inflammation/ Irritation (4545)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initially, the clinic reported of patient's condition 4 months post last treatment.At this point it was decided to continue to monitor patient's healing progress as gradual improvement was anticipated.Seven months post last treatment, follow up information was received showing lack of reparative course for patient's condition, and hence it was decided to report the incident due to its longevity.Investigation is on-going.
Event or Problem Description
Papular tip footprints with pie on décolleté 7 months post morpheus8 treatment.
Event or Problem Description
Papular tip footprints with pie on décolleté 7 months post morpheus8 treatment.
Additional Manufacturer Narrative
Initially, the clinic reported of patient's condition 4 months post last treatment.At this point it was decided to continue to monitor patient's healing progress as gradual improvement was anticipated.Seven months post last treatment, follow up information was received showing lack of reparative course for patient's condition, and hence it was decided to report the incident due to its longevity.Investigation is on-going.11-dec-2024: follow up report is submitted with corrections and investigation results.D5 - operator corrected to unknown.H6- health effect clinical code corrected.Investigation results: technical inspection of the device did not reveal any issues.Investigation attributed the root-cause to multiple user errors.Firstly, the treated area (décolleté) lacked any indication for morpheus8 treatment.Using numbing cream with high percentage of anesthetics could have predisposed the skin to initial intense inflammatory response.Treatment settings were not congruent with the recommended protocol, performed at incorrect depths at high energy on a bony area, adding to the inflammatory response.Further, the operator performed the last treatment on the skin that hasn't healed yet and still presented with inflammatory reaction per provider.The operator disregarded patient's medical background (skin related autoimmune disease), although contraindicated per ifu and most probably this further contributed to the inflammatory response.To summarize, multiple user errors led to the prolonged inflammatory state and the pie.

• 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: 20021746
• Report Number: 3010511300-2024-00545
• Device Sequence Number: 7690221
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: Other
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 12/11/2024
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White