Pure Enrichment PEHPVAL-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817387020596), received between May 8, 2024 and May 9, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BEAR DOWN BRANDS RECEIVED CALL FROM CUSTOMER ((B)(6)) ON (B)(6) 2024 REPORTING COMPLAINT. HEATING PAD BRAND NEW BOUGHT IN FEBRUARY. HER SON RECEIVED THIRD DEGREE BURNS AND NOW MUST HAVE SKIN GRAFT SURGERY. PRODUCT IS PEHPVAL-G. PURCHASED AT TARGET. DESCRIPTION ON WHAT OCCURED: BURN ON HIS BACK, HE HAD HIS SHIRT ON, IT WAS ON FOR FIFTEEN MINUTES AND THEN TURNED OFF. HE HAS A THIRD DEGREE BURN. EVENT HAPPENED ON (B)(6) 2024. S FIRST TIME THE SON USED IT. SENT A PICTURE TO DOCTOR AFTER EVENT (DATE OF CALL TO DOCTOR NOT CLEAR) AND THEY WENT TO URGENT CARE. SON WAS TAKEN TO URGENT CARE ON (B)(6) 2024. (B)(6). DIAGNOSIS WAS 1. BURN OF USPECIFIED BODY REGION, UNSPECIFIED DEGREE). PATIENT WAS GIVEN SILVER SULFADIAZINE 1% CREAM TO APPLY TOPICALLY TO AFFECTED AREA DAILY AND SENT HOME WITH BURN INSTRUCTIONS TO CARE FOR A THIRD DEGREE BURN. CUSTOMER STATED DURING THE (B)(6) 2024 CALL TO BDB THAT THE CREAM WAS NOT SUFFICIENT TO HEAL THE BURN. CUSTOMER PROVIDED DOCUMENT FROM UNKNOWN FNP (B)(6). (B)(6) UNKNOWN DATE, WHICH SHOWS THAT CUSTOMER'S SON HAD AN APPOINTMENT WITH DR. (B)(6) ON THURSDAY (B)(6) 2024. BEAR DOWN BRANDS DID NOT RECEIVE MEDICAL REPORT OF (B)(6) 2024 VISIT WITH DR. (B)(6). BEAR

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19275221 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) EMAILED BEAR DOWN BRANDS ON 19-AUG-2023 AND STATED THAT HER PARTNER HAD PURCHASED THE HEATING PAD FOR HER IN MAY AND SHE SUSTAINED SECOND DEGREE BURNS LAST WEEK (ASSUMED APPROXIMATE DATE OF INCIDENT AS 10-AUG-2023) BY USING IT. SHE HAS SOUGHT MEDICAL ATTENTION FOR THE BURNS. SHE WANTS TO KNOW OUR POLICY ON DEFECTIVE PRODUCTS AND WHAT THE COMPENSATION FOR THIS ISSUE WOULD BE. ON 24AUG23 (B)(6) REPLIED VIA EMAIL WITH ANSWERS TO THE FOLLOWING QUESTIONS: THE HEAT SETTING I HAD IT ON WAS LOW. SHE WAS IN MEXICO WHEN THE BURN OCCURRED. SHE WILL SEND PHOTOGRAPHS. SHE WANTS TO KNOW IF THERE IS FINANCIAL COMPENSATION FOR THE EXPENSES SHE INCURRED DUE TO THE BURN. ON 28/29-AUG-2023 (B)(6) CONFIRMED THAT THE UNIT WAS PURCHASED AT TARGET IN HAWAII. SHE CONFIRMED THE MODEL NUMBER AS PEHPVAL-G. THE CUSTOMER'S HOME ADDRESS IS (B)(6), THE UNIT WAS PURCHASED IN HAWAII AND THE INCIDENT OCCURRED IN MEXICO.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19274849 ↗