THE CELLFINA SYSTEM CP1 - EU 5036234

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-09-11 for THE CELLFINA SYSTEM CP1 - EU 5036234 manufactured by Ulthera, Inc., Merz Device Innovation Center.

MAUDE Entry Details

• Report Number: 3006560326-2019-00020
• MDR Report Key: 8992322
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-09-11
• Date of Report: 2019-08-15
• Date of Event: 2019-08-14
• Date Mfgr Received: 2019-08-15
• Device Manufacturer Date: 2019-04-01
• Date Added to Maude: 2019-09-11
• 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: 2019-09-11
• Model Number: CP1 - EU
• Catalog Number: 5036234
• Lot Number: 100118445
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• 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		2019-09-11