ExSept Plus 100 mLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00898021000105), received between Dec 22, 2023 and Dec 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023 (B)(6) WAS NOTIFIED BY THE FDA VIA EMAIL, THAT REPORT # MW5148319 HAD BEEN RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM. THE REPORT WAS SUBMITTED BY FRESENIUS MEDICAL CARE, A DISTRIBUTOR OF ANGELINI PHARMA INC. INFECTION PREVENTION PRODUCTS. THE REPORT STATED THAT A FEMALE PATIENT EXPERIENCED SWELLING OF THE NECK, AND SEVERE BREATHING DIFFICULTIES WHILE USING EXSEPT PLUS ANTISEPTIC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Swelling/ Edema

  MAUDE report 18384328 ↗