Xeroform 8884432000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884527014910), received between Apr 9, 2024 and Apr 9, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  THE CUSTOMER REPORTED AN 8-YEAR-OLD PATIENT WITH BURNS OF 80% OF THE TOTAL BODY SURFACE CAUSED BY THE EXPLOSION OF AN OIL PIPELINE IN (B)(6) 2023 IN THE UKRAINIAN CITY OF (B)(6), ABOUT 280 KM FROM THE SLOVAKIAN. THE CHILD WAS TRANSFERRED TO THE HOSPITAL IN CRITICAL CONDITION TWO DAYS AFTER THE INCIDENT. THERE WERE FIVE CRITICAL WEEKS OF SEVERE ELECTROLYTE IMBALANCES, CARDIORESPIRATORY INSTABILITY, AND SEVERE INFECTIONS, AND UNDER PEDIATRIC SURGERY AND INTENSIVE CARE MEASURES, SUCH AS REPEATED DEBRIDEMENT. AFTER SURGICAL INTERVENTIONS AND ARTIFICIAL TRACHEOTOMY, THE SITUATION WAS "STABILIZED". THE CHILD IS CURRENTLY RECEIVING SEVERAL TRANSPLANTS OF CULTURED SKIN CELLS (SO-CALLED KERATINOCYTES) IN ORDER TO OBTAIN COVERAGE OF THE SKIN. DUE TO THE DETECTION OF SEVERAL MULTIDRUG-RESISTANT GERMS, INTRAOPERATIVE LOCAL THERAPY LASTING SEVERAL WEEKS WAS RECOMMENDED WITH XEROFORM® (3% BISMUTH TRIOBROMPHENATE) ON 40-55% OF THE BODY SURFACE. THE PATIENT HAD NON-SPECIFIC SYMPTOMS SUCH AS FEVER, AGITATION, TUBULOPATHY AND GENERALIZED EDEMA, ACCOMPANIED BY BISMUTH OVERLOAD AND THE DETERMINATION OF BISMUTH IN THE URINE WAS PERFORMED. AN EXTREMELY HIGH BISMUTH VALUE OF 529 G/L (REFERENCE VALUE < 0.

  Patient problems: Fever; Swelling/ Edema

  MAUDE report 19075524 ↗
• InjuryApr 9, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  THE CUSTOMER REPORTED AN 11-YEAR-OLD PATIENT WITH BURNS OF 90% OF THE TOTAL BODY SURFACE CAUSED BY THE EXPLOSION OF AN OIL PIPELINE IN (B)(6) 2023 IN THE UKRAINIAN CITY OF IVANO-FRANKIVSK, ABOUT 280 KM FROM THE SLOVAKIAN BORDER. THE CHILD WAS TRANSFERRED TO THE HOSPITAL IN CRITICAL CONDITION TWO DAYS AFTER THE INCIDENT. AFTER FIVE CRITICAL WEEKS OF SEVERE ELECTROLYTE IMBALANCES, CARDIORESPIRATORY INSTABILITY, AND SEVERE INFECTIONS, AND UNDER PEDIATRIC SURGERY AND INTENSIVE CARE MEASURES, SUCH AS REPEATED DEBRIDEMENT. AFTER SURGICAL INTERVENTIONS AND ARTIFICIAL TRACHEOTOMY, THE SITUATION WAS "STABILIZED". THE CHILD IS CURRENTLY RECEIVING SEVERAL TRANSPLANTS OF CULTURED SKIN CELLS (SO-CALLED KERATINOCYTES) IN ORDER TO OBTAIN COVERAGE OF THE SKIN. DUE TO THE DETECTION OF SEVERAL MULTIDRUG-RESISTANT GERMS, INTRAOPERATIVE LOCAL THERAPY LASTING SEVERAL WEEKS WAS RECOMMENDED WITH XEROFORM® (3% BISMUTH TRIOBROMPHENATE) ON 30-50% OF THE BODY SURFACE. IN THE CASE OF NON-SPECIFIC SYMPTOMS, SUCH AS FEVER, AGITATION, RENAL TUBULOPATHY AND GENERALIZED EDEMA, A BISMUTH OVERLOAD WAS SUSPECTED, AND THE DETERMINATION OF BISMUTH IN THE URINE WAS PERFORMED. THERE WERE AN EXTREMELY HIGH BISMUTH VALUE

  Patient problems: Fever; Swelling/ Edema

  MAUDE report 19075382 ↗