Renalin 100 78397-846Recalls & reported problems
Medivators Inc. · Renalin 100 · Class 1
- 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 00677964011740), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FACILITY REPORTED AN EMPLOYEE SPLASHED RENALIN 100 ON HAND AND EXPERIENCED CHEMICAL EXPOSURE SYMPTOMS SUCH AS DISCOLORATION OF THE SKIN OF HIS FINGERS.
Patient problems: Chemical Exposure
MAUDE report 6458160 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.