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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZELTIQ AESTHETICS, INC. ZELTIQ EZ APP 6.2 ZELTIQ VACUUM APPLICATOR

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ZELTIQ AESTHETICS, INC. ZELTIQ EZ APP 6.2 ZELTIQ VACUUM APPLICATOR Back to Search Results
Model Number EZ APP 6.2
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Tissue Damage (2104)
Event Date 01/28/2011
Event Type  Injury  
Event Description

It is alleged that a (b)(6) female pt received coolsculpting treatment on (b)(6) 2011. The pt received one treatment with the 8. 0 applicator to lower abdomen and one treatment with 6. 2 applicator on each of the flanks. During treatment the applicator dislodged from the right flank and the right flank was retreated on (b)(6) 2011. Except for applicator dislodgement the office reports all treatments were uneventful. Post treatment phase was also uneventful. Approx 6-8 months following the treatment, the pt noticed hardness on both flanks, but not the abdomen. The hardness was not tender. The areas did not appear enlarged in volume. The physician administered steroids (date unk) to soften the tissue. Lipoatrophy was observed several weeks after injection, which is a common side effect of steroid injection.

 
Manufacturer Narrative

Zeltiq followed up with the physician's office to gather additional info. Per the physician's office, all the procedures were conducted successfully with no malfunctions. During treatment of the right flank the applicator dislodged. Applicator dislodgements can happen during treatment with pt movement, inadequate tissue drawn in the cup, etc and are not considered a device malfunction.

 
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Brand NameZELTIQ EZ APP 6.2
Type of DeviceZELTIQ VACUUM APPLICATOR
Manufacturer (Section D)
ZELTIQ AESTHETICS, INC.
4698 willow road
pleasanton CA 94588
Manufacturer Contact
gurvinder nanda
4698 willow road
pleasanton, CA 94588
9254742500
MDR Report Key2750280
MDR Text Key2895556
Report Number3007215625-2012-00007
Device Sequence Number1
Product Code OOK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080521
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 08/16/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEZ APP 6.2
Device Catalogue NumberBRZ-AP1-062-000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/16/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/14/2012 Patient Sequence Number: 1
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