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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VELASHAPE

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VELASHAPE Back to Search Results
Event Date 01/19/2009
Event Type  Injury  
Event Description

Underwent an initial velashape procedure at laser center and experienced excessive bruising on the legs. It was explained to the patient that there may be "some" bruising from the procedure, but the result was bruising from knee to hip on the exterior and partially on the internal part of both thighs. Very painful, red, swollen and hot to touch - needed icing for 48 hours and compression pants to be able to function. The center is looking into possible cancellation of contract for further treatments and took photos two days after treatment following complaint by patient. The patient found the procedure painful enough and the bruising excessive enough to warrant a report to the fda since it was highly advertised as the only fda approved non-surgical cellulite reduction procedure on the market and minor bruising possible. In early 2009 - went through a velashape treatment on abdomen, and inner and outer thighs. During treatment - experienced pain, especially on the legs, yet allowed to proceed. Within less than two hours from treatment - bruising began on inner and outer thigh area which ended up as a mass swelling, red, hot, bruising in the entire area treated. Although patient notified that treatment may result in some bruising, appeared dangerous to the patient's health and resulted in excessive pain for days after treatment. Patient reported bruising via email to laser center on the evening of the treatment and via phone the following morning. Center reported to regional manager who required patient to travel to facility to have photos taken for report two days after treatment. Bruising still highly visible and painful. Dose: 2x5 minutes per section. Frequency 2 x's. Route: subdermal. Diagnosis: to reduce cellulite. Event abated after use stopped: no.

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Type of DeviceVELASHAPE
MDR Report Key1293884
Report NumberMW5009649
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/21/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 01/21/2009 Patient Sequence Number: 1