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Model Number CK1 - EU |
Device Problem
Insufficient Information (3190)
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Patient Problem
Deformity/ Disfigurement (2360)
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Event Date 02/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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It is unknown if the device used during treatment is available for investigation.The device information for the cellfina disposable kit used during treatment is currently unknown.No additional information is available at this time.When additional information is received, a supplemental report will be filed.
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Event Description
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A physician reported to a merz affiliate on 22-aug-2019 that "dermal protrusions on the treatment site" had appeared on a patient following a cellfina treatment on (b)(6) 2019.On 02-sep-2019, additional information was provided by the physician stating, "protrusions that do not disappear after 3 months of treatment and a significant disability." no additional information is available at this time.
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Manufacturer Narrative
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Attempts to acquire additional information were made on 27-aug-2019, 10-sep-2019, and 13-sep-2019.The practice did not return the device used for treatment or provide a lot number for the disposables kit used for treatment.As such, a lot complaint history review and lot history record review could not be performed for the disposables kit used for this treatment.A review of the cellfina patient complaint trending analysis for the reported issue of skin surface convexity, depression, or other irregularity found that the issue has not occurred at a high enough frequency to generate a trend and will continue to be monitored.As the physician stated the cellfina devices performed as intended during treatment and no evidence of a device malfunction was identified during the patient investigation, it is unknown if a cellfina device caused or contributed to the event.However, a contributory role to the treatment with the cellfina system cannot be excluded with certainty.No additional information is available at this time.If additional information is received, a supplemental medwatch form will be submitted.
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Event Description
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Additional information was provided by the merz affiliate regarding this cellfina treatment.It was alleged that this young female patient was treated on the gluteal region and posterior/lateral regions of the thigh with approximately 40 or more releases at depths of 9mm, 10mm, and 6mm using the teardrop platform.The treatment lasted two hours and following treatment the patient was instructed to use compression and sanitary disposable pads for two to three days.This patient's bmi was less than 25 at the time of treatment.The treatment was performed by a physician who has been trained on the cellfina system, but has allegedly performed few treatments.The anesthesia used during treatment contained 1% lidocaine; equating to 50 ml.The patient was scheduled for a three month follow-up visit post-treatment.This was the patient's first cellfina treatment and no other cosmetic procedures were reported to have been performed on the treatment area.It was reported that the equipment performed as intended for this treatment and no intervention was performed following conclusion of the procedure.The affiliate reported that the components of the disposables kit used for treatment are not available for return.No additional information is available at this time.
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Search Alerts/Recalls
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