THE CELLFINA SYSTEM CK-1 5036030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-24 for THE CELLFINA SYSTEM CK-1 5036030 manufactured by Ulthera, Inc., Merz Device Innovation Center.

MAUDE Entry Details

• Report Number: 3006560326-2019-00014
• MDR Report Key: 8822589
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-07-24
• Date of Report: 2019-06-28
• Date of Event: 2019-02-09
• Date Mfgr Received: 2019-06-28
• Device Manufacturer Date: 2018-01-26
• Date Added to Maude: 2019-07-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. JESSICA CIOTTI
• Manufacturer Street: 1840 SOUTH STAPLEY DRIVE SUITE 200
• Manufacturer City: MESA AZ 85204
• Manufacturer Country: US
• Manufacturer Postal: 85204
• Manufacturer Phone: 4808288875
• Manufacturer G1: ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
• Manufacturer Street: 1840 SOUTH STAPLEY DRIVE SUITE 200
• Manufacturer City: MESA AZ 85204
• Manufacturer Country: US
• Manufacturer Postal Code: 85204
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THE CELLFINA SYSTEM
• Generic Name: CELLFINA SYSTEM
• Product Code: OUP
• Date Received: 2019-07-24
• Model Number: CK-1
• Catalog Number: 5036030
• Lot Number: 2018011204
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
• Manufacturer Address: 1840 SOUTH STAPLEY DRIVE SUITE 200 MESA AZ 85204 US 85204

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-24