MAUDE Adverse Event Report: ZELTIQ AESTHETICS, INC. ZELTIQ COOLADVANTAGE APPLICATOR

Model Number	BRZ-AP2-160-000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported tissue necrosis, which caused patient hospitalization and necessitated medical intervention to avoid serious complications, was assessed as a serious injury with a possible, although not established, relationship to the coolsculpting procedure.Diligent efforts have been made by allergan to gather more information on the device information and system logs, but no additional information has been received to date.Zeltiq (now allergan) was initially made aware of the reportable event on 12/19/2017, and an initial attempt to submit this mdr was made on 01/31/2018.However, due to transmission issues, this mdr is being re-submitted.Cdrh was notified on (b)(4) 2018 and has assigned ticket number (b)(4) for this issue.
Event or Problem Description
On (b)(6) 2017, allergan received report from a treatment provider that a patient received 6 coolsculpting treatments to the upper and lower abdomen and bilateral flanks on (b)(6) 2017 and had presented with redness, warmth and pain on the treated areas 4 days after treatment.The patient was prescribed clindamycin 300mg tid for 10 days, and bactroban topical ointment to be applied to the affected area every 8 hours for 3-5 days.On (b)(6) 2017, the patient was subsequently hospitalized for a fever of 103 degrees.He remained in the hospital for five days and was treated with iv antibiotics, pain medication, and steroids.A biopsy was performed and showed non-bacterial tissue necrosis.

• Brand Name: ZELTIQ COOLADVANTAGE APPLICATOR
• Common Device Name: ZELTIQ COOLADVANTAGE APPLICATOR
• Manufacturer (Section D): ZELTIQ AESTHETICS, INC.; 4410 rosewood drive; pleasanton CA 94588
• MDR Report Key: 8262725
• Report Number: 3007215625-2018-00003
• Device Sequence Number: 2056239
• Product Code: OOK
• UDI-Device Identifier: 00816417020575
• UDI-Public: 0100816417020575
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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
• Device Model Number: BRZ-AP2-160-000
• Device Catalogue Number: BRZ-AP2-160-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention