MAUDE Adverse Event Report: CRYOCONCEPTS DR SCHOLLS FREEZE AWAY SKIN TAG REMOVER; CRYOGENIC SKIN REMOVER

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a spontaneous report from the united states was received via email regarding a consumer (age and sex not provided).On an unspecified date, the consumer used dr.Scholls freeze away skin tag remover for skin tags.The details of how the consumer used the device were not provided.On an unspecified date after starting to use the device, the consumer experienced her skin burning, swelling, and bleeding.Subsequently, she went to her doctor.The consumer noted that she had second degree burns.No further information was provided.
Additional Manufacturer Narrative
Additional manufacturer narrative: complaint received from amazon consumer and we were unable to get additional information or the device returned.No further investigation can be completed at this time.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: CRYOGENIC SKIN REMOVER
• Manufacturer (Section D): CRYOCONCEPTS; 1100 convoy place; easton PA 18040
• Manufacturer (Section G): CRYOCONCEPTS; 1100 convoy place; easton PA 18040
• Manufacturer Contact: alex terranova ; 119 cherry hill road, suite 200; parsippany, NJ 07054 ; 8623281407
• MDR Report Key: 16965594
• Report Number: 3008812068-2023-00001
• Device Sequence Number: 5392518
• Product Code: GEH
• UDI-Device Identifier: 00888853003467
• UDI-Public: 0100888853003467
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 05/15/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown