Pure Enrichment PEHPWD2-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817387025010), 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

  ON (B)(6) 2024 (B)(6) EMAILED BEAR DOWN BRANDS TO REPORT: I AM REACHING OUT BECAUSE I SUFFERED THIRD DEGREE BURNS FROM A HEATING PAD I RECENTLY PURCHASED FROM (B)(6) ON (B)(6) 2024 BEAR DOWN BRANDS RECEIVED THE FOLLOWING REQUESTED DETAILS REGARDING THE INCIDENT: INCIDENT OCCURED ON 15JAN24, PRODUCT WAS ON LEVEL 5 AND USED FOR 20 MINUTES. (B)(6) REQUIRED A VISIT TO URGENT CARE ON (B)(6) 2024 WHERE THEY SENT OFF A BURN/WOUND CULTURE AND I REQUIRED TWO ANTIBIOTICS AND SPENT SEVERAL HUNDRED DOLLARS ON WOUND DRESSINGS. THEY INFORMED ME IT WAS A THIRD DEGREE BURN. (B)(6) PROVIDED PHOTOGRAPHS OF BURN. PHOTOGRAPHS OF THE BURN PROVIDED. MEDICAL RECORDS HAVE NOT BEEN PROVIDED TO DATE. SHE WAS USING THE PAD ON HER BACK FOR ACHES WITH NO SPECIFIC PREEXISTING CONDITION.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19275330 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CALLED BEAR DOWN BRANDS ON (B)(6) 2023 TO REPORT THAT HER HEATING PAD, PEHPWIDE HAD BURNED HER. CUSTOMER STATED SHE HAD A THIRD DEGREE BURN AND HAD GONE TO THE HOSPITAL FOR MEDICAL CARE. CUSTOMER DID NOT STATE THE ACTUAL DATE OF THE HOSPITAL VISIT. THE UNIT HAD BEEN USED PREVIOUSLY AND SHE COULD NOT REMEMBER WHAT LEVEL IT WAS SET ON BUT PROBABLY 3. SHE USUALLY USES THE PAD ONE HOUR PER SESSION. BEAR DOWN BRANDS CALLED CUSTOMER FOR FURTHER FOLLOW UP ON (B)(6) 2024. CUSTOMER STATED THAT SHE EXPERIENCED A BURN ON THEIR LEFT SIDE UPPER THIGH. SHE FELL ASLEEP NOT KNOWING SHE HAD LAID ON THE REMOTE AND THE HEATING PAD MUST HAVE TURNED ON ACCIDENTLY. ON (B)(6) CUSTOMER REPLIED TO VOICE MESSAGE LEFT BY BEAR DOWN BRANDS. CUSTOMER STATED THAT THEY HAD BEEN TO THE DOCTOR THREE TIMES. (B)(6) 2024 BEAR DOWN CALLED CUSTOMER AGAIN AND RECEIVED THE FOLLOWING ANSWERS: CUSTOMER CHANGED THE MODEL NUMBER OF THE PRODUCT FOR THIS INCIDENT TO PEHPWD2-G SHE WAS WEARING PANTS, SHE DOES NOT RECALL HOW LONG EXACTLY THE UNIT WAS IN USE, SHE FELL ASLEEP SHE HAD USED THE PAD FOR OVER 4 MONTS HER BURN HAS BEEN BEEN CLASSIFIED AS SECOND TO THIRD DEGREE AND SHE HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2024. CU

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19274616 ↗