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

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Fluid Discharge (2686); Cancer (3262)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
On 18-jan-2024, a spontaneous report from the united states was received via email regarding a 63-year-old male who used a dr.Scholls freeze away skin tag remover.On an unspecified date in (b)(6) 2023, reported as 6 months ago (relative to (b)(6) 2024), the consumer's wife topically applied the dr.Scholls freeze away skin tag remover to his lower back skin tag as he could not see the area properly.The skin tag did not freeze or fall off after application of the product.The day after application he could see a little bump in the mirror at the application site and it was sore to the touch.After a couple of days, the bump raised more.It was red and it protruded from the skin more than before.After 1 to 2 weeks the area started oozing and he believed it was infected, but he did not show it to his doctor.After a month, it was noted to be bigger and a size of a marble.It kept growing.Approximately 4 months after application, the consumer visited his doctor.The consumer thought it seemed like there was fluid under the bump.He received a referral to an oncologist surgeon.On (b)(6) 2023, the consumer had the growth removed from his back and a biopsy was taken.The size of the growth was noted to have been 5.3 cm x 2.6 cm x 1.5 cm.The biopsy revealed a well differentiated squamous cell carcinoma a keratocanthomatous type.From the surgery he had an incision with 4 by 4 scar with stitches that were painful.The area was healing well.It was anticipated that on (b)(6) 2024 he would have an appointment with a dermatologist and on 24-jan-2024, he would have an appointment with his oncologist.He thought he would have imaging done to see if the cancer had spread.On an unspecified date, the consumer asked the doctor and the surgeon if they thought it was related to use of the product, but they did not comment.No further information was provided.

• 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): SCHOLL'S WELLNESS COMPANY; 1100 convoy place; easton NJ 18040
• Manufacturer Contact: alex terranova ; 1100 convoy place; easton, NJ 18040 ; 8553552796
• MDR Report Key: 18704361
• Report Number: 3008812068-2024-00001
• Device Sequence Number: 7676786
• Product Code: GEH
• UDI-Device Identifier: 00888853003467
• UDI-Public: 0100888853003467
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D478237
• 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): 02/14/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/14/2024
• 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: CEPHALEXIN; LISINOPRIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 125 KG