Dr. Scholl's 1612171Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00311017405307), received between Oct 25, 2018 and Nov 21, 2018 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS CASE WAS REPORTED BY ANOTHER HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF HAEMATEMESIS ("(B)(6) ATE THIS AND HAD BLOODY VOMIT") IN A (B)(6) MALE PATIENT WHO RECEIVED DR SCHOLLS FREEZE AWAY DUAL ACTION CUTANEOUS SPRAY. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: ACCIDENTAL DEVICE INGESTION BY A CHILD "(B)(6) INFANT INGEST THIS" ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT EXPERIENCED HAEMATEMESIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPNOEA ("(B)(6) ATE THIS AND HAD DIFFICULTY BREATHING"). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH DR SCHOLLS FREEZE AWAY DUAL ACTION. AT THE TIME OF THE REPORT, THE HAEMATEMESIS AND DYSPNOEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSPNOEA AND HAEMATEMESIS WITH DR SCHOLLS FREEZE AWAY DUAL ACTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6). THIS (B)(6) PATIENT INGESTED SALICYLIC ACID, DIMETHYL ETHER, PROPANE AND EXPERIENCED HAEMATEMESIS ON THE NEXT DAY. ONLY HAEMATEMESIS IS UNLISTED ACCORDING TO SALICYLIC ACID, DIMETHYL ETHER, PROPANE REFE

  Patient problems: Vomiting

  MAUDE report 8095230 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE SITE BURN ("SHE RECEIVED A MAJOR BURN. SHE STATED THAT THE BURN IS 7.5CM. SHE STATED THAT IT IS VERY DEEP") IN A (B)(6) FEMALE PATIENT WHO RECEIVED DR SCHOLLS FREEZE AWAY DUAL ACTION CUTANEOUS SPRAY FOR THERAPEUTIC SKIN CARE TOPICAL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: CONSUMER REPORTED THAT THERE'S NO RELEVANT MEDICAL HISTORY. ON AN UNKNOWN DATE, THE PATIENT STARTED DR SCHOLLS FREEZE AWAY DUAL ACTION. ON (B)(6) 2018, 1 DAY AFTER STARTING DR SCHOLLS FREEZE AWAY DUAL ACTION, THE PATIENT EXPERIENCED MEDICAL DEVICE SITE VESICLES ("I HAD BLISTERS AFTER USING THIS.") AND MEDICAL DEVICE SITE SCAB ("IT TURNED INTO A HARD SCAB THAT POPPED."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MEDICAL DEVICE SITE BURN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SULFADIAZINE SILVER (SILVER SULFADIAZINE). DR SCHOLLS FREEZE AWAY DUAL ACTION WAS WITHDRAWN. ON (B)(6) 2018, THE MEDICAL DEVICE SITE VESICLES HAD RESOLVED. ON (B)(6) 2018, THE MEDICAL DEVICE SITE SCAB HAD RESOLVED. THE REPORTER PROVIDED NO

  Patient problems: Burn(s)

  MAUDE report 8043538 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF APPLICATION SITE BURN ("CHEMICAL BURN") AND CELLULITIS ("CELLULITIS OF HIS HAND / RIGHT HAND WOUND") IN A (B)(6) MALE PATIENT WHO RECEIVED DR SCHOLLS FREEZE AWAY DUAL ACTION CUTANEOUS SPRAY FOR PAPILLOMA EXCISION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO PERVIOUS INJURY OR SURGERY IN THE RIGHT HAND. NO PERTINENT PAST MEDICAL OR FAMILY HISTORY. NO DRUG USE. CONCURRENT CONDITIONS INCLUDED PENICILLIN ALLERGY, TOBACCO USER AND ALCOHOL USE. ON AN UNKNOWN DATE, THE PATIENT STARTED DR SCHOLLS FREEZE AWAY DUAL ACTION. ON THE SAME DAY, THE PATIENT EXPERIENCED APPLICATION SITE BURN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH SKIN EXFOLIATION, BLISTER, APPLICATION SITE PAIN, SKIN DISCOLOURATION, PAIN IN EXTREMITY, SKIN SWELLING, DERMATITIS AND ACANTHOSIS AND CELLULITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH INFLAMMATION OF WOUND. ON (B)(6) 2016, THE PATIENT EXPERIENCED HYPOAESTHESIA ("NUMBNESS OF RIGHT MIDDLE FINGER"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MUSCULOSKELETAL STIFFNESS ("STIFFNESS WIT

  Patient problems: Caustic/Chemical Burns; Cellulitis

  MAUDE report 8005590 ↗