MAUDE Adverse Event Report: SCHOLL'S WELLNESS COMPANY DR SCHOLLS COMPLETE CARE FREEZE AWAY SKIN TAG REMOVER; CRYOGENIC SKIN REMOVER

Lot Number	3251-2190
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05-nov-2024, this spontaneous report was received via a letter regarding a 64-year-old female consumer from the united states in association with the dr.Scholl's complete care skin tag remover.On (b)(6) 2024, the consumer used the dr.Scholl's complete care skin tag remover to her right neck, left shoulder near the neckline, and to an underarm.After using the product, the consumer experienced burns, redness, and skin discoloration on her right neck, on her left shoulder near the neckline, and on an underarm.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned.Subsequently no investigation for the device has been possible.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 COMPLETE CARE FREEZE AWAY SKIN TAG REMOVER
• Common Device Name: CRYOGENIC SKIN REMOVER
• 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: 20826007
• Report Number: 3008812068-2024-00003
• Device Sequence Number: 12994003
• Product Code: GEH
• UDI-Device Identifier: 00888853003467
• UDI-Public: 0100888853003467
• 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): 11/26/2024

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
• Device Expiration Date: 09/30/2026
• Device Lot Number: 3251-2190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female