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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The practice reported that the patient had a reaction to tumescent anesthesia solution immediately upon delivery prior to a cellfina procedure. Following the reaction, the procedure was not performed and the patient was admitted to a hospital as a precautionary measure. It is unknown what measures were taken with the patient to resolve the issue. The cellfina system device used during this treatment was not requested for return as the physician stated the adverse event occurred in response to the anesthesia and the cellfina equipment was unrelated. As the cellfina device serial numbers were not provided, a review of the lot complaint history and lot history record was not performed. A review of the cellfina patient complaint trend analysis revealed that the reported issue of "allergic reaction" has not occurred at a high enough frequency to generate a trend and will continue to be monitored. Based on the available information, it is confirmed that a cellfina device did not cause or contribute to the reported adverse event. No additional information is available at this time. If additional information is received, 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 301380437-2020-00008. 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 Description

On 17-jul-2020, merz/ulthera received a report from a practice regarding an adverse event associated with a cellfina treatment. The practice reported that a patient had a reaction to the tumescent anesthesia solution delivered prior to cellfina treatment and was taken to the emergency room. The practice was phoned on (b)(6) 2020; during this phone call, the physician reported that the patient experienced an allergic reaction to the anesthesia immediately upon delivery of the solution. Following this reaction, the cellfina procedure was aborted. The physician reported that the patient has a history of allergic reactions to anesthesia, which was identified after the event transpired. Additionally, the physician stated that it was unknown how much the tumescent anesthesia solution should be diluted relative to the patient's body weight and the patient was "very small". No additional information is available at this time.

• 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 ; 2628353300
• MDR Report Key: 12125886
• MDR Text Key: 269357085
• Report Number: 3006560326-2021-00004
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/06/2021 Patient Sequence Number: 1