N/A (REF MAX-A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825014612), received between Jul 10, 2023 and Jul 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Adhesive Too Strong” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2023Adhesive Too Strong; Adhesive Too Strong

  IT WAS REPORTED THAT XEROFORM GAUZE WAS USED TO TREAT A WOUND THAT RESULTED DURING PATIENT DISCHARGE WHEN THE COMPLAINT DEVICE'S STICKY ADHESIVE PULLED/TUGGED ON THE PATIENT SKIN, RIPPING A PIECE OF THEIR SKIN OFF WITH THE COMPLAINT DEVICE RIGHT UNDER THE NAIL. THERE WAS NO OTHER PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17295262 ↗
• InjuryJul 10, 2023Adhesive Too Strong; Adhesive Too Strong

  IT WAS REPORTED THAT XEROFORM GAUZE WAS USED TO TREAT A WOUND THAT RESULTED DURING PATIENT DISCHARGE WHEN THE COMPLAINT DEVICE'S STICKY ADHESIVE PULLED/TUGGED ON THE PATIENT SKIN, RIPPING A PIECE OF THEIR SKIN OFF WITH THE COMPLAINT DEVICE RIGHT UNDER THE NAIL. THERE WAS NO OTHER PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17295227 ↗