Valleylab E7512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524001067), received between Nov 27, 2018 and May 2, 2019 — classified as 1 injury, 1 malfunction.

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 16, 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 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING HERNIA PROCEDURE, NEW BORN PATIENT HAD BURN WHILE USING POSITIONED CAUDAL PLATE IN GLUTEAL REGION, AND LED TO EXTENDED HOSPITALIZATION.

  Patient problems: Burn(s); No Code Available

  MAUDE report 8573826 ↗
• MalfunctionNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, PEN WAS ON THE GENERATOR WITH A BRAND NEW RETURN ELECTRODE PAD. WHEN THE SURGERY WAS COMPLETED AND REMOVED THE CLAMPS HOLDING THE HUCK TOWELS, IT WAS FOUND THAT THE METAL CLAMPS HAD BURNED THE PATIENT'S SKIN, LEAVING TWO ROUND BURN MARKS AT THE INNER THIGH, BOTH 1CM IN DIAMETER EACH, BLACK SPOTS THAT TURNED WHITE. IT WAS DIAGNOSED AS SECOND DEGREE BURN AND WAS TREATED WITH SILVER SULFADIAZINE. THE ELECTRODE WAS NEW BUT THE PEN WAS NOT. THE DEVICE SHOWED THAT THE RETURN PAD WAS GROUNDED AT ALL TIMES.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8107987 ↗