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CHATTANOOGA 2761Recalls & reported problems

Djo, LLC · VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL · Class 2

Adverse event reports
7
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912292849), received between Dec 12, 2017 and Apr 30, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Electrical /Electronic Property Problem1
  • Electrical Overstress1
  • Intermittent Energy Output1
  • Unintended Electrical Shock1

Patient problems

  • Partial thickness (Second Degree) Burn3
  • Burn(s)2
  • Full thickness (Third Degree) Burn2
  • Electric Shock1
  • Lead(s), Burn(s) From1
  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT SUSTAINED 5 BURNS WHERE ELECTRODES WERE PLACES DURING TREATMENT THAT WERE TREATED TOPICALLY BY WOUND CARE USING STANDARD BURN CREAM AND INFECTION TREATMENTS.

    Patient problems: Burn(s); Unspecified Infection

    MAUDE report 21940269 ↗
  • InjuryDec 21, 2022Unintended Electrical Shock; Unintended Electrical Shock

    IT WAS REPORTED THAT THE UNIT ALLEGEDLY SHOCKED AND CAUSED A BURN TO PATIENT DURING TREATMENT.

    Patient problems: Burn(s); Electric Shock

    MAUDE report 16026891 ↗
  • InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SECOND DEGREE BURN FROM TREATMENT.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 12628361 ↗
  • MalfunctionDec 23, 2019Intermittent Energy Output; Intermittent Energy Output

    IT WAS REPORTED THAT THE "INTENSITY INTERMITTENTLY SURGES" DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9510522 ↗
  • InjuryAug 5, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT "THE UNIT WAS ORIGINALLY SET AT 44 BUT ABOUT 8 MINUTES IN GAVE AN OVERCURRENT ERROR & THE UNIT STOPPED WORKING-THE SET AT 35 AND CONTINUED TREATMENT WHEN FINISHED THE PATIENT HAD A BURN AND BLISTER". [SIC] NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 8860883 ↗
  • InjuryApr 11, 2019Electrical Overstress; Electrical Overstress

    IT WAS REPORTED THAT THE PATIENT RECEIVED A SMALL 2CM X 0.8CM BURN UNDER AN ELECTRODE. THE PATIENT WAS BEING TREATED FOR ACUTE BACK PAIN USING INTERFERENTIAL CURRENT (IFC) WITH CONSTANT VOLTAGE (CV). NURSING WAS IMMEDIATELY NOTIFIED, FOLLOWED BY A PHYSICIAN. THE WOUND WAS CLEANSED BY NURSING, SILVADENE WAS APPLIED, AND THE WOUND WAS COVERED BY A NON-STICK GAUZE, CHANGED TWICE A DAY. THE PATIENT WAS MONITORED AT A SKILLED NURSING FACILITY FOR SIGNS AND SYMPTOMS OF INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Full thickness (Third Degree) Burn; Lead(s), Burn(s) From

    MAUDE report 8503356 ↗
  • InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    COMPLAINT RECEIVED THAT ALLEGES "DURING AN INTERFERENTIAL E-STEM TREATMENT FOR A MUSCLE SPASM ON CHANNEL 2 AND 3 A PATIENT RECEIVED A BURN UNDER TWO ELECTRODE PADS. THE PATIENT WAS INSTRUCTED THAT THE INTENSITY SHOULD BE STRONG BUT NOT PAINFUL, AND THEY NEEDED TO INDICATE WHEN THE INTENSITY WAS SUFFICIENT FOR THEM, WHICH HE DID SO. ABOUT 2-3 MINUTES INTO THE 12 MINUTE TREATMENT HE ASKED FOR IT TO BE TURNED DOWN, WHICH IT WAS UNTIL HE INDICATED IT WAS A BETTER INTENSITY. ABOUT 3-4 MINUTES LATER HE AGAIN ASKED FOR IT TO BE TURNED DOWN, WHICH AGAIN IT WAS UNTIL HE INDICATED IT WAS BETTER. AFTER ABOUT A MINUTE HE COMPLAINED OF IT FEELING HOT/ BURNING DESPITE NOT HAVING ANY HEAT PACKS OR ICE ASSOCIATED WITH THE TREATMENT. HE WAS TOLD THAT WAS NOT NORMAL, AND HE HAD THE CHOICE TO CONTINUE WITH THE TREATMENT AND KEEP TURNING IT DOWN, OR THAT HE COULD TERMINATE THE TREATMENT. HE CHOSE TO TURN IT DOWN AGAIN, AND AFTER ABOUT 1 MINUTE ASKED FOR IT TO BE TURNED OFF. THERE WAS ABOUT 2 MINUTES LEFT ON THE TREATMENT. THE TREATMENT WAS GIVEN UNDER HIS SHIRT TO HIS RHOMBOID, THE LEADS WERE REMOVED AND HE WENT TO THE LOCKER ROOM. HE RETURNED TO SHOW ME HIS BURNS, AND HIS WOUNDS WERE CLEANED, TREATED

    Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

    MAUDE report 7109689 ↗

Other STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL 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.