MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number AG607401A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Allergic reaction on face 24hrs post morpheus8 treatment.The patient visited the emergency room 48 hours after treatment, where she received a steroid injection and anti-histamine therapy.

Manufacturer Narrative

Investigation is ongoing.A follow-up report will be submitted with investigation conclusions.

Manufacturer Narrative

The device was inspected and no technical issues were found.The operator used treatment settings congruent with the protocol.Investigation concluded that allergic reaction was brought on by individual hypersensitivity to the numbing cream applied prior to the morpheus8 procedure, or by the variety of additional active substances applied post treatment, and could have been further exacerbated by the morpheus8 procedure.The patient has fully recovered.

Event Description

Allergic reaction on face 24hrs post morpheus8 treatment.The patient visited the emergency room 48 hours after treatment, where she received a steroid injection and anti-histamine therapy.

• Brand Name: MORPHEUS8
• Type of Device: 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: 19104543
• MDR Text Key: 340224154
• Report Number: 3010511300-2024-00495
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Health Professional
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White