Prontosan® 400440Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964295751), received between Nov 21, 2017 and Dec 19, 2017 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2017Improper or Incorrect Procedure or Method

  AS REPORTED BY THE USER FACILITY: AN EMPLOYEE OF B. BRAUN (B)(4) IS DOING WARD TRAINING. SHE WAS GIVEN A RISK AWARENESS NOTICE, CONCERNING INTRAVENOUS ADMINISTRATION OF PRONTOSAN WOUND IRRIGATION SOLUTION. RISK AWARENESS NOTICE: FROM: (B)(6), CLINICAL RISK MANAGER AND (B)(6), CHIEF NURSE CLYDE SECTOR. TO: ALL ACUTE WARDS AND DEPARTMENTS DATE: (B)(6) 2017 RE: PATIENT EXPERIENCED CARDIOVASCULAR COLLAPSE FOLLOWING IV ADMINISTRATION OF PRONTOSAN IN ERROR. PLEASE BRING THIS TO ATTENTION OF ALL STAFF. A SERIOUS INCIDENT HAS OCCURRED WITHIN AN EMERGENCY IN DEPARTMENT CLYDE. FOLLOWING INSERTION OF A CANNULA, THE DOCTOR ACCIDENTALLY PICKED UP A PLASTIC VIAL OF PRONTOSAN WHICH IS USED FOR DEEP WOUND AND GAVE AS AN IV BOLUS (5 MLS). SOON AFTER INJECTION THE PATIENT EXPERIENCED TINGLING FROM FACE DOWNWARDS INVOLVING HIS WHOLE BODY AND FEELING OF FAINTING. THIS WAS QUICKLY FOLLOWED BY CARDIOVASCULAR COLLAPSE WITH AN UNRECORDABLE BLOOD PRESSURE. AN SCI IS UNDERWAY AND OUTCOME AND FULL RECOMMENDATIONS WILL BE SHARED. AN INITIAL LITERATURE REVIEW SHOWS NO EVIDENCE OF BENEFIT FROM USING THIS PRODUCT FOR WOUND IRRIGATION. TISSUE VIABILITY HAS ADVISED THEY DO NOT SEE A RISK TO WOUND MANAGEMENT BY REM

  Patient problems: Collapse; No Code Available; Tingling

  MAUDE report 7129250 ↗
• InjuryDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: AN EMPLOYEE OF B. BRAUN (B)(4) IS DOING WARD TRAINING. SHE WAS GIVEN A RISK AWARENESS NOTICE (SEE ATTACHMENT), CONCERNING INTRAVENOUS ADMINISTRATION OF PRONTOSAN WOUND IRRIGATION SOLUTION. RISK AWARENESS NOTICE: FROM: (B)(6), CLINICAL RISK MANAGER AND (B)(6), CHIEF NURSE CLYDE SECTOR. TO: ALL ACUTE WARDS AND DEPARTMENTS DATE: (B)(6) 2017 RE: PATIENT EXPERIENCED CARDIOVASCULAR COLLAPSE FOLLOWING IV ADMINISTRATION OF PRONTOSAN IN ERROR. PLEASE BRING THIS TO ATTENTION OF ALL STAFF. A SERIOUS INCIDENT HAS OCCURRED WITHIN AN EMERGENCY IN DEPARTMENT CLYDE. FOLLOWING INSERTION OF A CANNULA, THE DOCTOR ACCIDENTALLY PICKED UP A PLASTIC VIAL OF PRONTOSAN WHICH IS USED FOR DEEP WOUND AND GAVE AS AN IV BOLUS (5 MLS). SOON AFTER INJECTION THE PATIENT EXPERIENCED TINGLING FROM FACE DOWNWARDS INVOLVING HIS WHOLE BODY AND FEELING OF FAINTING. THIS WAS QUICKLY FOLLOWED BY CARDIOVASCULAR COLLAPSE WITH AN UNRECORDABLE BLOOD PRESSURE. AN SCI IS UNDERWAY AND OUTCOME AND FULL RECOMMENDATIONS WILL BE SHARED. AN INITIAL LITERATURE REVIEW SHOWS NO EVIDENCE OF BENEFIT FROM USING THIS PRODUCT FOR WOUND IRRIGATION. TISSUE VIABILITY HAS ADVISED THEY DO NOT SEE A RISK TO WOUND

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7129167 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: DURING THE PREPARATION OF A FENTANYL 150MCG INJECTION THERE WAS A MIX-UP CONCERNING THE DILUTING AGENT. INSTEAD OF NACL 0.9% (REF: (B)(4)), HEALTH CARE PROFESSIONAL TOOK PRONTOSAN WOUND IRRIGATION SOLUTION (REF: (B)(4)) AND INJECTED 7ML OF SOLUTION TO THE PATIENT (FEMALE, 1996, HYPOTONIC). THE PATIENT SHOWED ANAPHYLACTIC REACTIONS SUCH AS BURNING PAIN AT PLACE OF INJECTION, LOSS OF VISION AND MYDRIASIS FOR ABOUT 15-20 MINUTES. FURTHERMORE, THE PATIENT SHOWED DECREASED BLOOD PRESSURE (70MMHG), INCREASED HEART RATE (120BPM) AND AN ERYTHEMA (FULL-BODY). ACCORDING TO HEALTH CARE PROFESSIONAL, THE PATIENT RECOVERED WITHOUT CONSEQUENCES. PATIENT WAS GIVEN 0.8 LITERS NACL 0.9% AND 2MG CLEMASTIN (TAVEGYL®) INTRAVENOUSLY.

  Patient problems: Anaphylactic Shock; Burning Sensation; Erythema; Loss of Vision; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 7050857 ↗
• InjuryNov 21, 2017Improper or Incorrect Procedure or Method

  AS REPORTED BY THE USER FACILITY: DURING THE PREPARATION OF A FENTANYL 150MCG INJECTION THERE WAS A MIX-UP CONCERNING THE DILUTING AGENT. INSTEAD OF NACL 0.9% (REF: 3535800), HEALTH CARE PROFESSIONAL TOOK PRONTOSAN WOUND IRRIGATION SOLUTION (REF: 400484) AND INJECTED 7ML OF SOLUTION TO THE PATIENT (FEMALE, (B)(6), HYPOTONIC). THE PATIENT SHOWED ANAPHYLACTIC REACTIONS SUCH AS BURNING PAIN AT PLACE OF INJECTION, LOSS OF VISION AND MYDRIASIS FOR ABOUT 15-20 MINUTES. FURTHERMORE, THE PATIENT SHOWED DECREASED BLOOD PRESSURE (70MMHG), INCREASED HEART RATE (120BPM) AND AN ERYTHEMA (FULL-BODY). ACCORDING TO HEALTH CARE PROFESSIONAL, THE PATIENT RECOVERED WITHOUT CONSEQUENCES. PATIENT WAS GIVEN 0.8 LITERS NACL 0.9% AND 2MG CLEMASTIN (TAVEGYL®) INTRAVENOUSLY.

  Patient problems: Erythema; Loss of Vision; Low Blood Pressure/ Hypotension; Palpitations; Reaction; Reaction, Injection Site

  MAUDE report 7050854 ↗