THE REPORTED NUMBNESS, PARESTHESIA, LIMITED RANGE OF MOTION AND ULNAR CLAW WERE ASSESSED AS A SERIOUS INJURY RELATED TO THE USE OF THE COOLSCULPTING DEVICE. THE OCCURRENCE OF SENSORY AND MOTOR CHANGES IS A RISK INHERENT TO THE COOLSCULPTING PROCEDURE AND IS DETAILED IN THE COOLSCULPTING USER MANUAL. ALLERGAN DILIGENTLY ATTEMPTED TO GATHER ADDITIONAL INFORMATION ON THE DIAGNOSIS AND TREATMENT, DEVICE INFORMATION AND SYSTEM LOGS FROM THE CUSTOMER, BUT NONE HAS BEEN RECEIVED FROM THE CUSTOMER. TREATMENT OF THE UPPER ARM WITH THE COOLFIT APPLICATOR IS CONSIDERED AN OFF LABEL USE OF THE DEVICE. TREATMENT OF THE UPPER ARM WAS CLEARED WITH THE COOLADVANTAGE PETITE APPLICATOR, WHICH HAS A TREATMENT PROFILE OF -11 DEGREES CELSIUS AND A 35 MINUTE DURATION, BUT THIS WAS NOT THE APPLICATOR TYPE USED BY THE PRACTICE ON THIS PATIENT. ZELTIQ (NOW ALLERGAN) WAS INITIALLY MADE AWARE OF THE REPORTABLE EVENT ON (B)(4) 2017, AND AN INITIAL ATTEMPT TO SUBMIT THIS MDR WAS MADE ON 01/03/2018. HOWEVER, DUE TO TRANSMISSION ISSUES, THIS MDR IS BEING RE-SUBMITTED. CDRH WAS NOTIFIED ON 12/21/2018 AND HAS ASSIGNED TICKET NUMBER (B)(4) FOR THIS ISSUE.
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Patient 1
ON (B)(4) 2017, ALLERGAN WAS INFORMED OF AN EVENT IN WHICH A PATIENT, WHO WAS TREATED TO BILATERAL UPPER ARMS WITH COOLSCULPTING ON (B)(6) 2017 USING A COOLFIT APPLICATOR, WAS EXPERIENCING DIFFICULTY WRITING WITH HER LEFT HAND FOLLOWING TREATMENT AND WAS PRESENTING WITH ULNAR CLAW. ON (B)(6) 2017, UPON ASSESSMENT BY A NURSE PRACTITIONER, THE PATIENT PRESENTED WITH DECREASED ABILITY TO EXTEND THE FOURTH DIGIT OF THE LEFT HAND, CREATING A "CLAW" APPEARANCE, AND COMPLAINED OF PARTIAL NUMBNESS AND TINGLING SENSATION ON THE ULNAR SIDE OF THE LEFT HAND. DILIGENT EFFORTS HAVE BEEN MADE BY ALLERGAN TO OBTAIN DEVICE INFORMATION SUCH AS APPLICATOR SERIAL NUMBER, DEVICE SYSTEM LOGS, TREATMENT INFORMATION AND UPDATES ON THE PATIENT'S SYMPTOMS, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.