Pure Enrichment PEHPBACK-GRecalls & reported problems
Bear Down Consulting · Heating Pad for Back and Neck · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817387020732), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, THE CUSTOMER (COMPLAINANT) EMAILED BDB STATING THAT "SHE RECEIVED 3RD DEGREE BURNS ON HER BACK OF HER NECK ON (B)(6) 2024 AND WAS HOSPITALIZED FOR BEING SEPTIC AND IS NOW IN A WOUND CLINIC TO GET THE BURNS HEALED." THE CUSTOMER PROVIDED PHOTOS. PHOTOGRAPH WITH BLISTER IS THE DAY THE BURN OCCURRED (B)(6) 2024. THE SECOND PHOTO OF THE RED AREA WAS TAKEN (B)(6) 2024. ON (B)(6) 2024 BDB CUSTOMER SERVICE EMAILED CUSTOMER WITH QUESTIONS AND ON (B)(6) 2024 WITH FURTHER QUESTIONS. THE FOLLOWING IS THE DETAIL FROM THE CUSTOMER ANSWERS TO QUESTIONS: THE CUSTOMER PURCHASED THE PEHPBACK-G HEATING PAD IN 2023 AND HAD USED IT TWO TO THREE TIMES PER WEEK. THE CUSTOMER HAD NECK FUSION SURGERY ON (B)(6) 2023. ON (B)(6) 2024 THE CUSTOMER CAME HOME FROM WORK AND USED THE PAD ON LEVEL 3 FOR ABOUT 45 MINUTES. SHE FELT WARMTH BUT DID NOT FEEL ANY BURNING SENSATION WHEN USING THE PAD. THE CUSTOMER WAS TAKING MEDICATIONS FROM THE SURGERY, PERCOCET. SHE SAT UP, TOOK THE HEATING PAD OFF AND HER HUSBAND NOTICED THE BURN AND SAID HER BACK HAD A BLISTER ON IT AND LOOKED HORRIBLE. CUSTOMER WENT TO HER FAMILY DOCTOR ON (B)(6) 2024, HE TOOK PICTURES AND GAVE HER SILVERDINE CREAM. SHE DID THAT FOR
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 19638918 ↗
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- CONAIR HP15XFConair Corporation · Pad, Heating, Powered3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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