Xeroform 8884431302Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884527014897), received between Feb 10, 2020 and Feb 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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.

• InjuryFeb 10, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE CUSTOMER REPORTED THAT SHE PLACED A PIECE OF XEROFORM GAUZE OVER A SUPERFICIAL WOUND ON HER TOE AND COVERED IT WITH A BAND AID. THE BAND AID WAS SATURATED AND WHEN SHE REMOVED THE BAND AID, THERE WAS A FULL THICKNESS BURN AFTER WEARING SHOES FOR 4 HOURS. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE INJURY IS AT THE 2ND DIGIT OF HER LEFT TOE. SHE DID NOT CONSULT A CLINICIAN WHEN SHE FIRST HAD THE INJURY. SHE USED BACITRACIN OINTMENT AND WAS DOING SELF WOUND CARE. ON (B)(6) 2020, THE CUSTOMER CONSULTED A PODIATRIST AND WAS PRESCRIBED SANTYL OINTMENT. SHE USED IT FOR TWO DAYS AND IT DID NOT IMPROVE THE WOUND. ON (B)(6) 2020 AN X-RAY WAS DONE TO THE AFFECTED AREA. ON THE (B)(6) AN MRI WAS DONE AND THE CUSTOMER WAS DIAGNOSED WITH OSTEOMYELITIS. (B)(6) 2020 THE CUSTOMER WAS PRESCRIBED CEFEPIME 1 GRAM IV TWICE A DAY FOR 45 DAYS AND IS ON THE THIRD DAY OF TREATMENT AT HOME.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 9687313 ↗