MICROTEK 1 (UDI 00748426066414)Recalls & reported problems
Microtek Medical LLC · MINI C-ARM DRP, 54"" X 84"", 1-EACH · 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 00748426066414), received between Jul 12, 2024 and Jul 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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
- Material Puncture/Hole1
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.
MalfunctionJul 12, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE MINI C-ARM DRAPES ARE RIPPING/TEARING AT THE SEAMS WHILE THE SCRUB TECH IS DRAPING THEM. DOCTOR STATES "THIS IS NOT THE FIRST TIME THIS HAS HAPPENED WITH THESE DRAPES". NO PATIENT INJURY, INFECTIONS OR COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19730996 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.