Instaform 1Recalls & reported problems
CDR Systems Inc · Instaform Kit · 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 00628341930321), received between Nov 16, 2022 and Nov 16, 2022 — 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
- Improper or Incorrect Procedure or Method1
Patient problems
- Eye Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
CONTENTS OF THE BOTTLE HAD BEEN ALLOWED TO PRESSURIZE INSIDE THE CLOSED CONTAINER BY THE THERAPIST (USER). COMPONENTS OF CONTAINER EXPANDING PER THE NORMAL PROCESS FORCEFULLY PUSHED THE LID OFF AND IN WHAT WAS DESCRIBED AS A SCIENCE EXPERIMENT LIKE VOLCANIC ERUPTION AND SPRAYED INTO THE THERAPIST EYES AND ON SOME OBJECTS AND SURFACES OF THE ROOM INCLUDING THE FLOOR AND CEILING. THERAPIST(USER) SUBSEQUENTLY IT HAS BEEN REPORTED THAT THE THERAPIST (USER) MADE AN APPOINTMENT WITH AN OPHTHALMOLOGIST AND WAS PROVIDED EYE DROPS TO HELP LUBRICATE THE EYES TO MEDIATE DISCOMFORT WHILE HER EYES HEAL FROM THE INJURY. NO LONG TERM DAMAGE HAS BEEN REPORTED ONLY THAT THE DOCTOR IS MONITORING.
Patient problems: Eye Irritation
MAUDE report 15809137 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.