Aurora Hydrocolloide Adhesive Sheath SP301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741071966), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE LAYER OF THE MALE EXTERNAL CATHETER DID NOT STICK PROPERLY, AND NURSE STATED THAT THERE WERE AIR BUBBLES IN THE ADHESIVE LAYER. PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON 18OCT2021, IT WAS REPORTED THAT THE ADHESIVE LAYER OF THE MALE EXTERNAL CATHETER HAD FULL OF AIR BUBBLES AND THERE WAS TOO LITTLE PLAQUE IN THE INNER WALL, HENCE CUSTOMER WAS NOT ABLE TO UNROLL IT. SO, IT SEEMED AS WHETHER THERE WAS TOO LITTLE STICKY MATERIAL ON THE INSIDE. AND ALSO, USER STATED THAT EDGE OF MALE EXTERNAL CATHETERS WERE ROLLED OFF AND IT STRONGLY STUCK TO THE FINGERS. AS PER FOLLOW UP INFORMATION RECEIVED ON 21OCT2021, IT SEEMS THAT THERE WAS LESS ADHESIVE ON THE INSIDE OF THE CONDOM CATHETER, MAKING THEM STICK LESS WELL AND THERE WAS NO IMPACT TO THE PATIENT(S) DUE TO USE OF THESE DEVICES AND SEVERAL SHEATHS BUT NOT ALL OF THEM. BUT TOO MUCH TO IGNORE THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780193 ↗