• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INMODE LTD. MORPHEUS8; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
I received a treatment of morpheus8 on my chin and neck area and suffered severe consequences.Immediately afterwards, i had a great deal of swelling, pain, and itching and still had redness a month later.All of the literature said that the redness should only occur for a few days.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MORPHEUS8
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
INMODE LTD.
MDR Report Key16861525
MDR Text Key314577268
Report NumberMW5117220
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Age64 YR
Patient SexFemale
Patient RaceWhite
-
-