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

Model Number CK-1 US

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

Patient Problem Deformity/ Disfigurement (2360)

Event Type  Injury  

Manufacturer Narrative

The author of the literature article did not report any malfunctions or device deficiencies occurred during treatment.Multiple attempts for additional information regarding this event and availability of associated devices were performed on 18-aug-2021, 03-sep-2021, and 08-sep-2021; however, the reporter has not responded at this time.Therefore, an investigation of the lot history record for the cellfina disposable kit or the device history record for the cellfina motor module used during this treatment were not possible.A review of the cellfina patient complaint trend analysis revealed the reported issue of anetoderma has not occurred at a high enough frequency to generate a trend and will continue to be monitored.The patient investigation determined it is unconfirmed if a cellfina system device caused or contributed to the event.However, the patient's condition is potentially permanent; therefore, this case was deemed reportable per a serious injury.A contributory role of the cellfina system cannot be excluded with certainty.No additional information is available at this time.If additional information becomes available, a supplemental medwatch form will be submitted.

Event Description

Merz product safety received information on 12-aug-2021 regarding a cellfina adverse event within a published article that was identified during a literature review.Review of the full text provided revealed allegations of anetoderma-like skin lesions after cellfina treatment of one individual.According to the article, a "(b)(6) woman with no known medical history presented for cosmetic evaluation of cellulite of the buttocks.She had no history of previous surgeries or treatments in the area.At the 6-week follow-up, festooning of areas of subcised tissue on the left and right upper buttocks was noted.Initially, this finding was believed to likely resolve over the course of a few months; however, it persisted.At 4- and 6-month follow-ups, the patient was noted to have skin-colored round dermal plaques on the left and right upper buttocks, resembling anetoderma.A punch biopsy from the right lateral buttocks was submitted for evaluation to determine whether the skin showed signs of anetoderma.Histology did not support the diagnosis of anetoderma because it showed mild perivascular chronic inflammation without loss of elastic fibers.We hypothesize that these anetoderma-like plaques are related to postprocedural skin laxity or abnormal healing herniations; however, the pathophysiology is unclear.Although we intended to treat the "dimple-type" cellulite of our patient, it is possible that we unmasked concomitant skin laxity or another factor that contributed to this outcome.Our patient did have noticeable skin laxity of the inferior and lateral buttocks before the procedure which may have predisposed her to this outcome.To address the possibility of underlying skin laxity in our patient, she received micro-focused ultrasound technology (ultherapy; merz north america, inc., raleigh, nc) to these sites but had only very mild improvement." no additional information is available at this time.

• Brand Name: CELLFINA SYSTEM
• Type of Device: CELLFINA SYSTEM
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 13900 w. grandview parkway; sturtevant WI 53177
• MDR Report Key: 12448925
• MDR Text Key: 282297512
• Report Number: 3006560326-2021-00013
• 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: health professional,literatur
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TUMESCENT LIDOCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR