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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS INC. ZELTIQ BREEZE CONTROL UNIT

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ZELTIQ AESTHETICS INC. ZELTIQ BREEZE CONTROL UNIT Back to Search Results
Catalog Number BRZ-CG1-CUB-110
Event Date 09/14/2010
Event Type  Injury  
Event Description

On (b)(6) 2011 - zeltiq was notified that a patient has an on-going skin reaction from a procedure that was performed on (b)(6) 2010.

 
Manufacturer Narrative

It is alleged that during treatment on (b)(6) 2010, clinician experienced two system messages (thermal fluctuation; treatment stopped) while treating pt's left abdomen. After each system message, applicator was removed, skin assessed and determined to be normal. Clinician successfully treated patient's right side, then re-attempted left side twice and experienced two more system messages (treatment stopped). Skin was assessed and described as normal. A review of the device treatment logs revealed no abnormalities; the device operated normally as designed. On (b)(6) 2010, patient complained to office of skin discoloration on left side. Silvadene (burn cream) was prescribed. On (b)(6) 2010, patient was seen by clinician and found to have "redness at treated site without major pain. " on (b)(6) 2010, patient reported that her skin had "peeled off" and remained with a dark mark. On (b)(6) 2010, patient was seen by clinician and described skin as "lighter after peeling. " patient was given triple action cream and aquaphor. Case is further complicated by multiple repeated uses of laser (medlite 1064, manufactured by conbio) on (b)(6) 2010, (b)(6) 2010 and (b)(6) 2010. On (b)(6) 2010, patient was also prescribed tret/kojic/hc (0. 05%/5%/0. 5%). On (b)(6) 2010, patient was also prescribed epicream. On (b)(6) 2010, clinician noted patient's skin was getting lighter. More laser treatments were completed on (b)(6) 2010, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011 and (b)(6) 2011. On (b)(6) 2011, patient was advised to stop the treatments for at least 8 weeks to see how the skin is improving. On (b)(6) 2011, patient underwent her last medlite laser treatment and it was noted that her skin color was improving.

 
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Brand NameZELTIQ BREEZE CONTROL UNIT
Type of DeviceZELTIQ BREEZE
Manufacturer (Section D)
ZELTIQ AESTHETICS INC.
4698 willow road
pleasanton CA 94588
Manufacturer Contact
louis-pierre marcoux
4698 willow road
pleasanton , CA 94588
9254742500
MDR Report Key2281208
Report Number3007215625-2011-00002
Device Sequence Number1
Product CodeOOK
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/06/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberBRZ-CG1-CUB-110
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/06/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/05/2011 Patient Sequence Number: 1
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