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

Model Number CK-1

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

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Pain (1994); Deformity/ Disfigurement (2360)

Event Date 01/04/2019

Event Type  Injury  

Event Description

Merz (b)(4) affiliate reported information via email on 22-mar-2021 regarding an adverse event involving a cellfina system.Per the information provided: "patient.Was treated with cellfina for the treatment of thighs and buttocks on (b)(6) 2019 by one of our doctors.The patient indicated severe pain during treatment.Once at home, the patient reports bleeding and pain.Radiofrequency is recommended.Days later, bruises appear that later became 2 large fibroids, according to the patient.Subsequently, the patient consults a plastic surgeon, who performs two plastic surgeries on the affected area.The need for a third intervention is not ruled out." additional information was received from merz (b)(4) affiliate on (b)(6) 2021 which corrected the initially reported patient treatment date to (b)(6) 2019.This patient underwent approximately 25 releases using the narrow release during cellfina treatment, and most were performed at a 6mm depth with some 10mm depth releases.On an unknown date after treatment, the patient provided a photograph showing two protrusions/areas of convexity on the left buttock.The patient was allegedly scheduled for a follow-up appointment in (b)(6) 2020; however, she did not attend.Attempts were made to determine if the protrusions were an inflammatory subcutaneous response to the treatment or a true protrusion due to the release of the fibrous tract that causes the dimple; however, the patient never came to perform the ultrasounds for diagnosis.This was the patient's only treatment with cellfina, and according to the information provided had two liposuction procedures several years before cellfina treatment.According to the report, the cellfina equipment performed as intended and no malfunctions occurred during treatment.In an effort to address the reported issue of protrusions on the left thigh, the patient allegedly underwent two plastic surgeries and one radiofrequency procedure on unknown dates.No additional information has been provided at this time.

Manufacturer Narrative

The reporter stated the cellfina disposable kit used during this treatment has been discarded, and the lot number of this device is not available.Attempts to gain additional information regarding this event are ongoing.No additional information is available at this time.When the investigation is completed or additional information is obtained, a supplemental medwatch will be filed.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 merz (b)(4), 3013840437.It has since been identified that the ulthera establishment registration number, 3006560326, 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 Description

Merz (b)(6) affiliate reported information via email on 22-mar-2021 regarding an adverse event involving a cellfina system.Per the information provided: "patient.Was treated with cellfina for the treatment of thighs and buttocks on (b)(6) 2019 by one of our doctors.The patient indicated severe pain during treatment.Once at home, the patient reports bleeding and pain.Radiofrequency is recommended.Days later, bruises appear that later became 2 large fibroids, according to the patient.Subsequently, the patient consults a plastic surgeon, who performs two plastic surgeries on the affected area.The need for a third intervention is not ruled out." additional information was received from merz (b)(4) affiliate on (b)(6) 2021 which corrected the initially reported patient treatment date to (b)(6) 2019.This patient underwent approximately 25 releases using the narrow release during cellfina treatment, and most were performed at a 6mm depth with some 10mm depth releases.On an unknown date after treatment, the patient provided a photograph showing two protrusions/areas of convexity on the left buttock.The patient was allegedly scheduled for a follow-up appointment in (b)(6) 2020; however, she did not attend.Attempts were made to determine if the protrusions were an inflammatory subcutaneous response to the treatment or a true protrusion due to the release of the fibrous tract that causes the dimple; however, the patient never came to perform the ultrasounds for diagnosis.This was the patient's only treatment with cellfina, and according to the information provided had two liposuction procedures several years before cellfina treatment.According to the report, the cellfina equipment performed as intended and no malfunctions occurred during treatment.In an effort to address the reported issue of protrusions on the left thigh, the patient allegedly underwent two plastic surgeries and one radiofrequency procedure on unknown dates.No additional information has been provided at this time.

Manufacturer Narrative

The reporter stated the cellfina disposable kit used during this treatment has been discarded, and the lot number of this device is not available.Attempts to gain additional information regarding this event are ongoing.No additional information is available at this time.When the investigation is completed or additional information is obtained, a supplemental medwatch will be filed.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 merz north america, (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.

Manufacturer Narrative

The practice reported the cellfina disposable kit used during this treatment was discarded, and the lot number of this device was not recorded / unknown.This patient has sought legal action; therefore, no additional attempts to obtain information regarding this event was possible.The physician stated the cellfina devices performed as intended, and no malfunctions or device deficiencies occurred during treatment.As the actual device was discarded and no lot number information was provided, an investigation of the devices used during this treatment was not possible.A review of the cellfina patient complaint trend analysis revealed the reported issues of pain, bleeding, bruising/ecchymosis, and skin surface convexity, depression, or other irregularity have 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, medical intervention was performed on this patient and 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.This case was previously submitted on time, in accordance with regulatory reporting guidelines for medical device reports, via mfr number 301380437-2021-00003.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 merz north america, 3013840437.It has since been identified that the ulthera establishment registration number, 3006560326, 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.

• Brand Name: THE CELLFINA SYSTEM
• Type of Device: 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: 12927754
• MDR Text Key: 285926704
• Report Number: 3006560326-2021-00011
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K192185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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
• Device Operator: Health Professional
• Device Model Number: CK-1
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TUM ANESTHESIA (500ML OF NACL 0.9% + 0.5 MG)
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female