MAUDE Adverse Event Report: SCHOLL'S WELLNESS COMPANY DR SCHOLLS FREEZE AWAY SKIN TAG REMOVER; CRYSURGICAL ACCESSORIES

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Ecchymosis (1818); Pain (1994)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report from the united states was received on 11-jun-2024 via email regarding a 52-year-old, female who used the dr.Scholls freeze away skin tag remover.On (b)(6) 2024, additional information was received from a consumer.On (b)(6) 2024 , the consumer used dr.Scholls freeze away skin tag remover once, according to package instructions.The next day after using the product, the consumer experienced burning, swelling, and bruising.Also reported as a burn which turned into a bruise.Over the next several days the bruising progressed her whole left shoulder area and over the chest area.On (b)(6) 2024, she went to an emergency room and was diagnosed with cellulitis.She was given an antibiotic (route not confirmed) which did not work.On (b)(6) 2024, her symptoms progressed so she saw an orthopedic oncologist as the consumer thought it was affecting her prosthesis as her pain in her arm (the same side as the prothesis) was so bad she had troubles moving her arm.She was admitted to a hospital on (b)(6) 2024.She had a biopsy and cultures taken.The oncologist noted she was misdiagnosed as her symptoms were due to ecchymosis and not cellulitis.She was told the freeze part of the product caused the blood vessels to burst and bleed.As of (b)(6) 2024, the swelling, pain, and bruising was ongoing.She anticipated having an appointment with a dermatologist on (b)(6) 2024.No additional information was provided.
Additional Manufacturer Narrative
Additional manufacturer narrative: complaint received from consumer and consumer stated she threw the product away, so we were unable to retrieve lot information or the product for investigation or testing.This report and the information submitted under this report do not constitute an admission that the device or scholl's wellness or any of its employees caused or contributed to the event described within this report.

• Brand Name: DR SCHOLLS FREEZE AWAY SKIN TAG REMOVER
• Common Device Name: CRYSURGICAL ACCESSORIES
• Manufacturer (Section D): SCHOLL'S WELLNESS COMPANY; 119 cherry hill road; suite 200; parsippany NJ 07054
• Manufacturer (Section G): SCHOLL'S WELLNESS COMPANY; 119 cherry hill road; suite 200; parsippany NJ 07054
• Manufacturer Contact: rob brown ; 119 cherry hill road; suite 200; parsippany, NJ 07054 ; 7590680635
• MDR Report Key: 19671531
• Report Number: 3008812068-2024-00002
• Device Sequence Number: 13544544
• Product Code: GEH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GABAPENTIN
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 78 KG