Coag-Sense PT/INR Patient Self-Test System 200221Recalls & reported problems
Coagusense Inc. · Coag-Sense PT/INR Patient Self-Test System · Class 2
- 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 00861900000381), received between Aug 31, 2023 and Aug 31, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
- Output Problem1
- Use of Device Problem1
Patient problems
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Output Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Output Problem
SEE INITIAL USER REPORT MEDWATCH REPORT (MW5118699).
Patient problems: Stroke/CVA
MAUDE report 17667618 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.