Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. THE CELLFINA SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERZ NORTH AMERICA, INC. THE CELLFINA SYSTEM Back to Search Results
Model Number CK-1 US
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Laceration(s) (1946); Pain (1994); Scar Tissue (2060); Scarring (2061); Anxiety (2328); Blood Loss (2597)
Event Date 03/06/2020
Event Type  Injury  
Manufacturer Narrative
Based on the information provided thus far; no malfunctions of a cellfina device were alleged.Unsuccessful attempts to gather information regarding the practice details and treatment date were performed on 11-jun-2020 and 02-jul-2020.No additional information is available at this time.If additional information becomes available, a supplemental report will be submitted.
 
Event Description
Merz/ulthera received a report from a patient via email on (b)(6) 2020 regarding a cellfina adverse event.The reporter stated, "here are some photos of my butt/legs since a medical doctor performed cellfina on me.Do you care that he is doing this to people? i have asked for the doctor to pay for a plastic surgeon to repair it and he refuses.I have deep scarring 3+ months post treatment.I have consulted a plastic surgeon and other cellfina experts who say that the machine was used incorrectly.I want my legs restored." no additional information is available at this time.
 
Manufacturer Narrative
A product evaluation was not performed as the practice stated that the cellfina disposable kit used during treatment was not available for return.The physician stated that the equipment performed as intended during treatment, and no information was obtained during the investigation that would indicate a malfunction occurred.An evaluation of the service history of the control module used during treatment was not performed as cellfina devices are not serviceable equipment.An evaluation of the lot complaint history was not performed as the lot number of the cellfina disposable kit was not provided.A review of the device history record for the cellfina system control module revealed a non-conformance was opened to address incorrect specifications for load voltage tests.The non-conformance was found to be a documentation error and determined to have no potential impact on this event.No deviations or rework were noted during the manufacture of this device, and all required testing was passed prior to distribution.The patient investigation found the cellfina system devices used during treatment did not malfunction.It is unconfirmed whether a cellfina system device caused or contributed to this event.However, 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.A review of the cellfina patient complaint trending report revealed that none of the reported issues of anxiety, bleeding, bruising/ecchymosis, laceration, scar (minor), or tenderness/soreness/pain/sensitivity to touch have occurred at a high enough frequency to generate a trend and will continue to be monitored.No additional information is available at this time.If additional information is received, a supplemental report will be submitted.
 
Event Description
Merz/ulthera received a follow-up report from the patient via email on 05-jul-2020 regarding this cellfina adverse event.The reporter stated, "i had the procedure done (b)(6) 2020.The only reason i haven't written more is because i am trying hard to work with the provider.I met with the doctor about a month ago now and he agreed to refund the price and offered to have his office treat the scars.I asked for reimbursement for an estimate i received from a plastic surgeon; he said he would have to talk to someone.Then i got an email saying that they would not cover the repair by the plastic surgeon but that i could get repair by them.He has not refunded the cost of the cellfina as he stated he would.I have sent a final email to request this.I need to have the repair done so if he will keep his word and refund the cost that will help with the repair.I will share the information soon.I'm sure you want to follow up on any providers not using your equipment properly.The plastic surgeon and his assistant agreed that, in their opinion, it was user error with the machine." on (b)(6) 2020, the physician that treated the patient provided additional information regarding the event.The physician stated the patient was treated on the buttocks and posterior thighs, and confirmed that during treatment the patient experienced pain and required a second dose of anesthesia.Immediately following treatment, the patient was bleeding and required compression of the treatment area for approximately 30 minutes.The physician stated he directed to patient to use silicone gel to prevent scarring; however, noted the patient did not use it.The physician stated that he felt the scarring was mild and offered scar revision treatment for free, but the patient did not schedule.On 29-jul-2020, the patient sent a follow-up email containing more information stating "the procedure was extremely painful and i questioned the anesthetic.I let them know he and assistants that at the dentist it always takes lidocaine a longer time to take effect and we let it sit in my mouth for longer than usual.During the procedure i questioned the procedure due to it being so painful; stating that it was hurting very badly and asking if the machine was working properly.At one point the assistant asked me about the pain, she said you seem to be calling out (in pain) at the end of the cut.I told her yes absolutely, it feels as if edge of it getting caught on my skin.The wounds are congruent with this.Back to procedure day, about three-quarters of the way through my legs began shaking like they did when i was in labor.It should be noted that i have a high pain tolerance.After surgery i had to stay in extensive bandages for 4 days, with lesser bandages for 2 weeks.During the 2 weeks, to include at the end of the 2 weeks i was still bleeding.In fact, bleed through bandages onto my chair at work.I also bled down the side of the toilet that second week.It has improved certainly.But it has caused me anxiety, i might even say anguish.No additional information is available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
THE CELLFINA SYSTEM
Type of Device
THE CELLFINA SYSTEM
Manufacturer (Section D)
MERZ NORTH AMERICA, INC.
13900 w. grandview parkway
suite 200
sturtevant, wi
MDR Report Key10226290
MDR Text Key201254639
Report Number3006560326-2020-00006
Device Sequence Number1
Product Code OUP
Combination Product (y/n)N
PMA/PMN Number
K192185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model NumberCK-1 US
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received07/02/2020
Supplement Dates Manufacturer Received06/09/2020
Supplement Dates FDA Received08/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EPINEPHRINE; LIDOCAINE WITH BICARBONATE
Patient Outcome(s) Other;
-
-