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

Model Number CK-1 US

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Pain (1994); Scar Tissue (2060); Distress (2329); Deformity/ Disfigurement (2360); Impaired Healing (2378); Needle Stick/Puncture (2462); Swelling/ Edema (4577)

Event Date 03/31/2019

Event Type  Injury  

Manufacturer Narrative

Per the initial medwatch report, the event occurred in the months and years following treatment in (b)(6) 2019.The reporter did not allege any malfunctions or device deficiencies occurred during treatment.As no contact information for the reporter or treating practice were provided, no attempts for information could be performed.Therefore, an investigation of the lot history record for the cellfina disposable kit or device history record for the cellfina motor module was not possible.A review of the current version of the cellfina patient complaint trend analysis for the conditions of "edema," "skin surface convexity, depression, or other irregularity," "tenderness/soreness/pain/sensitivity to touch," "scar/keloid," "anxiety," "bleeding," and "bruising/ecchymosis" revealed that the reported issues have not occurred at a high enough frequency to generate a trend.These issues will continue to be monitored.All symptoms reported by the patient are expected risks per the current instructions for use (ifu) for the cellfina system.The reporter alleged issues that have not healed for years following treatment; therefore, permanent damage cannot be excluded with certainty.A contributory role of the cellfina system cannot be excluded with certainty.As a result, this event was deemed reportable as a serious injury.No additional information is available at this time.If additional information becomes available, an additional medwatch form will be submitted.

Event Description

On (b)(6) 2022, this patient's spontaneous medwatch report was received in regard to the patient's cellfina treatment in 2019.The patient alleged: "after my cellfina procedure, several large lumps and bulges of scar tissue developed on my butt and thighs.The lumps stuck out right above the cellfina incision scars.Over the months and years it took to recover and as the swelling went down, the lumps became more prominent and my thighs became more apparently deformed and disfigured.Cellfina has deformed my butt and thighs as well as left me with pain in those areas.When pressed, there are painful pinches and tightness from the scar tissue lumps.The scar tissue has not healed over time, and still after over three years, the painful bulges remain.This terribly appears to be permanent damage and disfigurement.Doctors have said there is no way to undo the damage and any attempt to repair the damage is extraordinarily risky and costly.It took over a year to heal from the bruising, bleeding stains, wide scars and swelling.Also, the scar tissue lumps and deformities are permanent damage.The horrible side effects and ongoing struggles have caused me serious mental distress as well.It has caused me immense and continual harm." no additional information is available 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 ; 2628353396
• MDR Report Key: 13829425
• MDR Text Key: 291456402
• Report Number: 3006560326-2022-00001
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CK-1 US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability