MAUDE Adverse Event Report: PRONOVA LABORATORIES DR. SCHOLL'S FREEZE AWAY MAX PLANTAR WART REMOVER; CRYOGENIC WART 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
Additional Manufacturer Narrative
The device was not returned.Subsequently no investigation for the device was possible.
Event or Problem Description
On (b)(6) 2023, a spontaneous report from the united states was received via email regarding a female (age unknown).On (b)(6) 2023, the consumer used a dr.Scholl's freeze away max plantar wart remover on a small wart on her inner left arm.Approximately an hour after application, she experienced intense pain, burning, and swelling at the site.She took ibuprofen and used cold compresses.The next day her symptoms were worse, and she went to an emergency room.She was diagnosed with a 2nd degree burn which was about the size of a dime.She was given a tetanus shot, pain medication, instructions on sterile dressing changes every 4 hours, and was prescribed oral and topical antibiotics.

• Brand Name: DR. SCHOLL'S FREEZE AWAY MAX PLANTAR WART REMOVER
• Common Device Name: CRYOGENIC WART REMOVER
• Manufacturer (Section D): PRONOVA LABORATORIES; kruitad 16; muiden, noord-holland 1398C P; NL 1398CP
• Manufacturer (Section G): SCHOLL'S WELLNESS COMPANY; 119 cherry hill road; suite 200; parsippany NJ 07054
• Manufacturer Contact: alex terranova ; 119 cherry hill road; suite 200; parsippany, NJ 07054 ; 8623281407
• MDR Report Key: 17912907
• Report Number: 3015733082-2023-00001
• Device Sequence Number: 12421166
• Product Code: GEH
• UDI-Device Identifier: 00888853003214
• UDI-Public: 0100888853003214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D435080
• 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): 10/11/2023

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: 09/29/2023
• Initial Report FDA Received Date: 10/11/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female