Prontosan® 400441Recalls & reported problems
B. Braun Medical Inc. · Prontosan® Wound Irrigation Solution, 350 mL Bottle · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964295782), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Diarrhea1
- Increased Intra-Peritoneal Volume (IIPV)1
- Nausea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON (B)(6) 2025 THE FOLLOWING INFORMATION WAS PROVIDED: HEALTHCARE PROFESSIONAL ACCIDENTALLY ADMINISTERED APPROXIMATELY 40 ML OF PRONTOSAN WOUND IRRIGATION SOLUTION INTRA-ABDOMINALLY THROUGH THE DRAINAGE. THE PATIENT IS COMPLAINING OF NAUSEA, MUCOUS-WATERY DIARRHEA, AND SOME LAB VALUES ARE OUTSIDE THE NORMAL RANGE. AFTER ADMINISTERING A LARGE AMOUNT OF FLUIDS (NACL), THE VALUES HAVE SLIGHTLY IMPROVED. THE HEALTHCARE PROFESSIONAL WOULD LIKE TO IRRIGATE AGAIN, BUT AFTER CONSULTING WITH THE SENIOR PHYSICIAN, HE ADVISED AGAINST IT. THE HEALTHCARE PROFESSIONAL'S REMAINING QUESTION IS WHETHER ANYTHING CAN STILL BE DONE RETROSPECTIVELY, SUCH AS ADMINISTERING ANTIBIOTICS OR SIMILAR MEASURES. THE PATIENT IS IN THE EMERGENCY ROOM. BASED ON THE INFORMATION AVAILABLE, IT WAS UNCLEAR WHETHER THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO ANOTHER INCIDENT OR DUE TO THE INTRA-ABDOMINAL ADMINISTRATION OF PRONTOSAN. SEVERAL INQUIRIES WERE MADE, AND ON (B)(6) 2025 THE FOLLOWING INFORMATION WAS PROVIDED: THIS IS A KNOWN TUMOUR PATIENT WITH ADENOCARCINOMA OF THE RECTUM, WHICH WAS APPARENTLY COMPLETELY REMOVED. THE PATIENT IS FEMALE, BORN IN 1975. SHE HAD ALREADY BEEN DISCHARGED FROM HOSPITAL, HAD A DRAIN
Patient problems: Diarrhea; Increased Intra-Peritoneal Volume (IIPV); Nausea
MAUDE report 22902575 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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