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PERFORMA 551968Recalls & reported problems

Performance Health Supply, LLC · PERFORMA CLOTH 2" X 3.5" RECTANGLE - 4/PK · Class 2

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 10885914070649), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Smoking” (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.

Most reported problems

Device problems

  • Smoking1
  • Sparking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 19, 2021Smoking; Sparking; Smoking; Sparking

    THE CUSTOMER REPORTED THAT THE THERAPISTS WERE USING THE ELECTRICAL STIMULATION MODALITY ON A PATIENT AND THERE WAS A SPARK AND SOME SMOKE AT THE LOCATION OF THE WIRE ATTACHING TO THE PAD. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12848709 ↗

Other Electrode, Cutaneous devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.