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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ ZELTIQ - COOLSCULPTING -

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ZELTIQ ZELTIQ - COOLSCULPTING - Back to Search Results
Event Date 11/02/2011
Event Type   
Event Description

This is concerning the fda approved coolsculpting procedure which is the non invasive answer to liposuction. This procedure is advertised as if it is painless and glamorous. When given the procedure pain meds are not offered which further glamorous the procedure. "after" the procedure, you are given an instruction sheet telling you that you "may" experience pain, tingling, itching, etc. By day 3, i was in so much pain i thought i was going to pass out. I did a search online for reviews and learned that most people experience this level of pain. Since the procedure usually requires several treatments to work it ends up being a waste of money because most people will not go back for the second treatment due to the level of pain. Today, almost a week later i am still in incredible pain and taking 800 mg motrin every few hours. Thank god i had motrin. Otherwise, i would have had to go to the er to deal with the pain. In hind site, your fat is frozen and over several weeks your fat liquifies and the docs don't think pain meds are necessary for this type of process! this report is not specific to the facility where i had my procedure. According to the online reviews no pain meds is the standard. I think this is because when you leave the dr's office after the procedure your fat is still frozen so you feel no pain at that time. The person can let you go home at that point with a clear conscious because you leave with a smile on your face not knowing the pain you will experience the next day! it is irresponsible that this procedure is offered without pain medication.

 
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Brand NameZELTIQ - COOLSCULPTING -
Type of DeviceZELTIQ - COOLSCULPTING -
Manufacturer (Section F)
ZELTIQ
Manufacturer (Section D)
ZELTIQ
Device Event Key2356425
MDR Report Key2334988
Event Key2231864
Report NumberMW5023040
Device Sequence Number1
Product CodeOOK
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2011
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? Yes
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 11/08/2011 Patient Sequence Number: 1
Treatment
ZELTIQ - COOLSCULPTING -
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