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PerformancePlus™ A10005Recalls & reported problems

Graphic Controls Acquisition Corp · Class 2

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 10813150020227), received between May 17, 2018 and May 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Component Missing” (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

  • Component Missing1
  • Defective Component1
  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • No Information1

Recent adverse event reports

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

  • InjuryMay 17, 2018Defective Component; Component Missing; Manufacturing, Packaging or Shipping Problem

    PRODUCT IS DEFECTIVE; 3 OF 5 ELECTRODES ARE MISSING A CONNECTOR REQUIRED TO USE THE DEVICE. PRODUCT PACKAGING IS ALSO INCORRECTLY MARKED WITH MFR'S ADDRESS THAT IS NO LONGER CORRECT.

    Patient problems: No Information

    MAUDE report 7525614 ↗

Other Electrode, Cutaneous devices

All Electrode, Cutaneous devices →

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