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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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