MAUDE Adverse Event Report: INMODE LTD INMODE MULTI-SYSTEM; DIOLAZEXL

Model Number	AG605985A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evidence of the alleged event was provided by the clinic.At the moment it is impossible to assess the alleged clinical ae without any photo or medical report that support the description of the case.We decided to report the case to hc based on the patient description.
Event or Problem Description
Patient states that he has a burn in genitals area after diolazexl treatment.He went to a cosmetic plastic surgeon and an emergency room doctor that reportedly stated that he has irreparable damage and will require reconstructive surgery.No photos or any other medical records were received as of 02/19/2023.

• Brand Name: INMODE MULTI-SYSTEM
• Common Device Name: DIOLAZEXL
• Manufacturer (Section D): 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: 16402955
• Report Number: 3010511300-2023-00181
• Device Sequence Number: 11585686
• Product Code: GEX
• UDI-Device Identifier: 07290016633269
• UDI-Public: 07290016633269
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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: AG605985A
• Device Catalogue Number: AG605985A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2019
• 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 Sex: Unknown