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MICROTEK 1 (UDI 00748426034598)Recalls & reported problems

Microtek Medical LLC · ISODrape UROLOGICAL DRAPE, 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 00748426034598), received between Jan 26, 2023 and Jan 26, 2023 — 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.

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.

  • MalfunctionJan 26, 2023Material Puncture/Hole; Material Puncture/Hole

    IT WAS REPORTED THAT THERE WAS A TEAR IN THE UROLOGICAL DRAPE. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16248986 ↗

Other Drape, surgical devices

All Drape, surgical devices →

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