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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNERON MEDICAL LTD. VELASHAPE III
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SYNERON MEDICAL LTD. VELASHAPE III Back to Search Results
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Partial thickness (Second Degree) Burn (2694)
Date of Event 04/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Under investigation.
 
Event or Problem Description
Female patient (b)(6) years old with skin type 3 underwent ultrashape power and velashape combined treatment on (b)(6) 2018 on the inner thigh area.According to the patient, the velashape treatment was performed for 10 min at 43 degrees follow by a treatment with ultrashape power.No burning was observed after the velashape treatment.During the ultrashape treatment the customer indicated that the patient felt a little more heat, but did not complain of burning.When the treatment was over, the skin was a little red bur not broken.On (b)(6) 2018, patient complained about burn on the inner thigh area.The company made multiple attempts to reach patient, however we were not able to get any additional information.
 
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Brand Name
VELASHAPE III
Common Device Name
VELASHAPE III
Manufacturer (Section D)
SYNERON MEDICAL LTD.
syneron medical ltd
industrial zone, po box 550
yokneam illit,
IS 
MDR Report Key7544455
Report Number3003772750-2018-00001
Device Sequence Number2239642
Product Code NUV
UDI-Device Identifier07290109952031
UDI-Public07290109952031
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K122579
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/24/2018
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
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2018
Initial Report FDA Received Date05/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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