Pure Enrichment PEHPAD24-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853975005644), received between May 8, 2024 and Jun 21, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fire” (1 report).

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.

• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 16MAY2024 (B)(6) CALLED BEAR DOWN BRANDS CUSTOMER SERVICE AND STATED THAT WHEN SHE WAS USING THE HEATING PAD IT GOT REALLY HOT AND MADE HER SKIN WELT. WAS USING HEATING PAD ON LOWER BACK AND SIDE. HER SIDE NOW HAS WELTS. SHE SHOWED HER PARENTS AND THEY TOLD HER TO CALL US AND TOLD HER TO SUE US. SHE STATES SHE DOES NOT WANT TO SUE US. SHE RECENTLY RECEIVED AS GIFT FROM HER MOTHER-IN-LAW. THIS WAS THE FIRST TIME SHE USED IT. IT WAS PLUGGED INTO A WALL OUTLET AND WAS USED ON LEVEL 3 FOR ABOUT 15 MINUTES. WHEN ASKED IF SHE RECEIVED MEDICAL CARE SHE STATED YES. ASKED IF SHE WENT TO DOCTOR, SHE STATED THAT HER JOB PAYS THE DOCTOR. WHEN ASKED IF THEY DESCRIBED THE LEVEL OF BURNS, SHE STATED, "LIKE THIRD DEGREE BURNS". SHE STATED SHE DOES HAVE PICTURES OF THE BURNS.

  Patient problems: Burn(s)

  MAUDE report 19586345 ↗
• InjuryMay 8, 2024Fire; Fire

  (B)(6) CALLED BEAR DOWN BRANDS ON 08:15 AM ON (B)(6) 2023 TO REPORT THAT THE PREVIOUS DAY, (B)(6) 2023 THE HEATING PAD CAUGHT ON FIRE, THE CORD MELTED AND CAUGHT ON FIRE AND THAT ALL THE PAD BURNED AND ONLY THE VERY TIIP OF IT IS LEFT. SHE WAS BURNED ON THE BACK. SHE STATED THAT SHE WENT TO THE EMERGENCY ROOM FOR TREATMENT. (IT IS IMPLIED BUT NOT STATED THAT SHE WENT TO THE ER ON (B)(6) 2023) IT WAS BEING USED IN HER LIVING ROOM AND HAD BEEN ON FOR ABOUT 2 HOURS. SHE USES THE UNIT EVERY DAY. BEAR DOWN REQUESTED PHOTOGRAPHS OF HER BURN BUT (B)(6) REFUSED SAYING IT WAS A HIPPA VIOLATION FOR US TO REQUEST THE PHOTOS. SHE DID NOT PROVIDE SPECIFICS ON THE TYPE OR EXENT OF THE BURN. BEAR DOWN REQUESTED THE PAD RETURNED OR PHOTOS OF THE PAD AND ANNA SAID THAT THERE WAS NOTHING LEFT OF THE PAD, SHE COULD NOT PROVIDE NOR COULD SHE PROVIDE PHOTOS. SHE DID NOT STATE THAT THERE WAS ANY PROPERTY DAMAGE. THE UNIT WAS PURCHASED ON AMAZON ON (B)(6) 2022.

  Patient problems: Burn(s)

  MAUDE report 19274595 ↗