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Contour 24 Q7000183Recalls & reported problems

Quality Electrodynamics LLC · 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 00814848020423), received between Jun 23, 2023 and Jun 23, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

  • Improper or Incorrect Procedure or Method1

Patient problems

  • Partial thickness (Second Degree) Burn1

Recent adverse event reports

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

  • InjuryJun 23, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    QUALITY ELECTRODYNAMICS RECEIVED A COMPLAINT FORWARDED FROM SIEMENS THAT A CONTOUR 24 RF COIL CAUSED A PATIENT BURN. THE BURN WAS ON BACKSIDE OF RIGHT WRIST AND WAS A DIME - NICKEL SIZED BLISTER. THE PATIENT WAS WEARING SCRUBS PROVIDED BY THE HOSPITAL AND WAS NOT SEDATED. THE PATIENT DID NOT REQUEST THAT THE SCAN BE STOPPED. THE PATIENT CHOSE NOT TO SEEK ADDITIONAL MEDICAL CARE FOR THE BURN. THE CONTOUR COIL WAS BEING USED BY ITSELF (WITH NO OTHER COILS) AND WAS POSITIONED OVER THE PATIENT'S PELVIC REGION. PER THE TECHNOLOGIST'S MEMORY: 1. THERE WERE NO PADS BETWEEN THE PATIENTS LEGS. 2. THERE WAS PADDING BETWEEN THE COIL AND BORE. 3. IT IS UNKNOWN IF THERE WERE PADS BETWEEN THE PATIENT' HIPS AND ARMS. 4. IT IS UNKNOWN IF THERE WERE PADS BETWEEN THE PATIENT'S HAND AND THE COIL, BUT THE TECHNICIAN STATED THAT THE PATIENT'S HAND WAS NOT CONTACTING THE COIL AT THE BEGINNING OF THE SCAN. IT IS BELIEVED THAT THE PATIENT MAY HAVE INADVERTENTLY SHIFTED HER/THE COIL'S POSITION DURING THE SCAN, WHICH COULD HAVE CAUSED THE HARD HOUSING OF THE COIL TO CONTACT HER WRIST RESULTING IN THE BURN. THE COIL WAS RETURNED TO SIEMENS AND SUBSEQUENTLY TO QUALITY ELECTRODYNAMICS AFTER THE INCIDENT.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 17191593 ↗

Other Coil, Magnetic Resonance, Specialty 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.