MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. THE CELLFINA SYSTEM

Model Number CK1-US

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

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

As the reporter stated she would not provide contact information for the treating practice and alleged to be filing legal action, no additional information related to the patient's treatment or cellfina devices used during treatment are available for investigation.A review of the cellfina patient complaint trending analysis for the reported issue of "scar (major)/keloid" revealed the issue has not occurred at a high enough frequency to generate a trend and will continue to be monitored.The patient investigation found it is unknown if any cellfina system devices used during treatment malfunctioned, and it is unconfirmed whether a cellfina system device caused or contributed to this event.However, as permanent damage to a body structure could not be ruled out based on the information provided, this event was deemed serious following discussion with the merz product safety team.No additional information is available at this time.If additional information is received, a supplemental report will be submitted.(b)(4).

Event Description

A patient phoned a merz/ulthera sales representative on (b)(6) 2020 and reported an adverse event following cellfina treatment.During the phone call, the patient alleged she has permanent scarring resulting from cellfina treatments approximately two years ago.The patient also stated that she has not went into the sun for two years because of concerns it might make the scarring worse.No other information was provided.The patient stated she would have her lawyer follow-up as she did not want to provide any contact information.As the patient did not provide her contact information and alleged she was pursuing legal action, no additional attempts for information are possible at this time.

• Brand Name: THE CELLFINA SYSTEM
• Type of Device: THE CELLFINA SYSTEM
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• Manufacturer Contact: robert wdowicki ; 13900 w. grandview parkway; sturtevant, WI 53177 ; 2628353300
• MDR Report Key: 12125917
• MDR Text Key: 269433032
• Report Number: 3006560326-2021-00005
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• PMA/PMN Number: K192185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CK1-US
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other