Alcavis 50 500 mLRecalls & reported problems
Angelini Pharma Inc. · Electrolytic Chloroxidizer High Level Disinfectant. · Class 2
Data updated Oct 18, 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 00898021000051), received between Oct 20, 2017 and Oct 20, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Chemical Spillage” (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
Device problems
- Chemical Spillage1
- Improper or Incorrect Procedure or Method1
Patient problems
- Injury1
- Skin Irritation1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2017Improper or Incorrect Procedure or Method; Chemical Spillage
ANGELINI PHARMA INC. WAS RECEIVED A COMPLAINT FILLED WITH (B)(4) ABOUT AN ADVERSE EVENT INVOLVING ALCAVIS 50. ON MARCH 1ST, (B)(4) WAS CONTACTED BY THE PATIENT ABOUT AN INCIDENT THAT HAPPENED ON (B)(6) 2017. THE PATIENT STATED THAT WHILE USING ALCAVIS 50 TO CLEAN THE CATHETER WHILE PREPARING FOR HIS PERITONEAL DIALYSIS, HE SPILLED ALCAVIS 50 ON HIS UNDERPANTS. HE DID NOT NOTICE THAT HIS UNDERWEAR WAS WET AND WENT TO BED WITH THE WET GARMENTS. IN THE NEXT MORNING, HE FELT THAT THE GENITAL AREA WAS UNCOMFORTABLE AND NOTICED HIS UNDERPANTS WAS DISCOLORED. HE THEN REALIZED THAT HE HAD SPILLED ALCAVIS 50 ON HIMSELF AND WENT TO BED WITHOUT EXCHANGE IT. HE NOTICED THAT THE GENITALS WERE REDDISH AND SENSITIVE; HE THEN SHOWERED AND WASHED THE AFFECTED AREA WITH ANTIMICROBIAL SOAP, TREATED WITH HYDROGEN PEROXIDE, AND WITH TRIPLE ANTIBIOTIC OINTMENT. TWO/THREE DAYS LATER, HE HAD A VISIT WITH HIS NEPHROLOGIST WHO REFERRED HIM TO THE PRIMARY DOCTOR, AND THIS TO HIS UROLOGIST. WITH THE UROLOGIST, HE BEGAN TREATMENT WITH LIDOCAINE GEL (4%) AND CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM. REGION IS STILL HAVING AN OPEN WOULD AND IS STILL PAINFUL. PATIENT IS DIABETIC AND UNDERGOES HYPERBARIC
Patient problems: Injury; Skin Irritation; Superficial (First Degree) Burn
MAUDE report 6966376 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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