PMI P4500Recalls & reported problems
Progressive Medical, Inc. · PMI Single Use REM Grounding Pad w/ Attached Cord · Class 2
Data updated Oct 13, 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 00812608020744), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- Skin Tears1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
PATIENT HAD HER SKIN RIPPED OFF ONTO THE GROUNDING PAD. PATIENT IS HAVING TO HAVE SKIN GRAFTS, DONOR SITE. THEY WERE HAVING TO... FIX THE AREA ON THE PATIENT THAT WAS DAMAGED DUE TO THE PRODUCT. PATIENT WAS 81 YEARS OLD, 160 LBS, ALLERGIES TO TAPE, LATEX AND RUBBER. PAD WAS REMOVED SLOWLY, FROM DISTAL END, BY RN. THE PROCEDURE WAS 198 MINUTES. THE PAD WAS PLACED ON THE LEFT LATERAL THIGH. SURGERY WAS TISSUE REARRANGEMENT AND SITE PREP OF PERINEUM SURGERY.
Patient problems: Skin Tears
MAUDE report 22667992 ↗
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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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