Austin A-AU-10-122SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850017635418), received between Mar 13, 2025 and Mar 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  CHLORAPREP IS HAVING AN ADVERSE AFFECT WITH THE ADHESIVE ON THE DRAPE. ONCE THEY APPLY THE CHLORAPREP THE ADHESIVE WON'T STAY DOWN AND THEY ARE HAVING TO ADD TAGADERM TO KEEP IT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600413 ↗
• MalfunctionMar 13, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  CHLORAPREP IS HAVING AN ADVERSE EFFECT WITH THE ADHESIVE ON THE DRAPE. ONCE THEY APPLY THE CHLORAPREP THE ADHESIVE WON'T STAY DOWN AND THEY ARE HAVING TO ADD TAGADERM TO KEEP IT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599539 ↗
• MalfunctionMar 13, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  CHLORAPREP IS HAVING AN ADVERSE EFFECT WITH THE ADHESIVE ON THE DRAPE. ONCE THEY APPLY THE CHLORAPRET THE ADHESIVE WON'T STAY DOWN AND THEY ARE HAVING TO ADD TAGADERM TO KEEP IT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599254 ↗