MAUDE Adverse Event Report: ZELTIQ COOLSCULPTING; DERMAL COOLING PACK/VACUUM MASSAGER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/02/2018

Event Type  Injury  

Event Description

Zeltiq coolsculpting: large applicator (newer one that is 45 min) for the lower abdomen: was told reduced nerve pain with more recently approved fda device: however i had excruciating nerve pain - 600 mg gabopentin, 400 mg ibuprofen yet no relief; the labeling/messaging/information for this device should be clearly updated and revised - "rare cases where patients have experienced nerve pain"??! not true! (b)(6) coolsculpting and read blogs, everyone is complaining about this pain.I hope that fda can encourage the company to provide more honest information to hcps who in turn can provide more accurate information to their patients."no downtime" "no pain" "go straight tomsork after" - all inaccurate statements regarding this device!.

• Brand Name: COOLSCULPTING
• Type of Device: DERMAL COOLING PACK/VACUUM MASSAGER
• Manufacturer (Section D): ZELTIQ
• MDR Report Key: 7168561
• MDR Text Key: 96655579
• Report Number: MW5074413
• Device Sequence Number: 1
• Product Code: OOK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 73