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

Model Number	CK1-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Deformity/ Disfigurement (2360)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cellfina ck-1 device used during treatment was discarded by the practice; therefore, an evaluation of the actual device was not possible.A review of the lot complaint history for this lot of ck-1 kits revealed no other complaints related to the reported issues have been alleged against this lot.A review of the lot history record for this lot revealed no non-conformance's, deviations, or rework was associated with the manufacture of this lot and all devices passed required testing prior to distribution.A review of the cellfina patient complaint trend analysis revealed the reported issues of "anetoderma" and "hematoma" have not occurred at a high enough frequency to generate a trend, and both will continue to be monitored.According to the treating physician, there was no malfunction of the cellfina equipment used during the treatment and the device performed as intended.Based on the information, it is unconfirmed whether the cellfina device caused or contributed to the event.However, a contributory role to the treatment with the cellfina device 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.This case was previously submitted on time, in accordance with regulatory reporting guidelines for medical device reports, via mfr number#: (b)(4).Due to a site consolidation, the mfr reportable event numbers used for submitting fda medwatch forms for ultherapy and cellfina products was updated to use the complaint file establishment registration number for (b)(4).It has since been identified that the ulthera establishment registration number (b)(4), should be used for ulthera and cellfina reportable event numbers.As such, this case is being resubmitted with an updated mfr number to align with the ulthera establishment registration number.
Event or Problem Description
A physician phoned merz/ulthera on (b)(6) 2020 and stated that he treated a patient with cellfina approximately two years ago, and the patient alleged to have out-pouching of tissue throughout the buttocks.No pain was reported.During follow up with the physician on (b)(6) 2020, he stated the patient was treated twice (b)(6) 2018 and (b)(6) 2018 on the buttocks and posterior thighs.Immediately following treatment, the patient experienced "some expected hematoma formation (per patient as she did not return to clinic for photos like after first treatment despite recommended her to) and during the patient's most recent follow up appointment he observed "anetoderma like out-pouching in some of the treated areas." the patient is reportedly undergoing venus freeze treatments to resolve the issue.No additional information is available at this time.

• Brand Name: THE CELLFINA SYSTEM
• Common Device Name: 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: 12917661
• Report Number: 3006560326-2021-00003
• Device Sequence Number: 5112037
• Product Code: OUP
• UDI-Device Identifier: 00840763100414
• UDI-Public: 00840763100414
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K192185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2019
• Device Model Number: CK1-US
• Device Catalogue Number: 5036030
• Device Lot Number: 2017091042
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TUMESCENT ANESTHESIA; TUMESCENT ANESTHESIA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Female