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Valleylab E7510-25DBRecalls & reported problems

Covidien LP · REM Polyhesive (TM) Infant Patient Return Electrode · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884524001050), received between Jul 25, 2018 and Jul 25, 2018 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Burn(s)1
  • Burn, Thermal1
  • Skin Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 25, 2018Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, AN IRRITATION OF THE SKIN ON THE RIGHT EXTERNAL FEMUR OF PATIENT WAS IDENTIFIED POSTOPERATIVELY IN THE POSTANAESTHESIA CARE UNIT. THE HYPOSPADIAS OPERATION WAS PERFORMED IN SUPINE POSITION WITH THE DEVICE AND A MONOPOLAR SWITCH PENCIL WITH NEEDLE ELECTRODE. THE PATIENT RETURN ELECTRODE WAS GLUED AT THE BACK. DURING THE OPERATION THERE WERE NO ABNORMALITIES. THE TEST PROTOCOLS WERE ADDED AND NO MALFUNCTIONS WERE DETECTED ON THE GENERATOR. A PHOTO SUBMITTED SHOWING THE SKIN AT THE THIGH PART WITH SKIN BURN.

    Patient problems: Burn(s); Burn, Thermal; Skin Irritation

    MAUDE report 7718280 ↗

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Sources and updates

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