BOUFFANT CAP
Received Mar 29, 2016
Report 1417592-2016-00025 · MDR key 5532195
Device
Generic name
Bouffant Cap
Manufacturer
Medline Industries, Inc.Catalog number
CRI1004Z
Lot number
26315060024
Product problems
- Patient-Device Incompatibility
Patient
25 YR
- Irritation
- Irritation
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THREE STUDENTS DEVELOPED EYE IRRITATION AND SKIN IRRITATION ON THEIR FOREHEAD AFTER WEARING THIS CAP. ONE STUDENT WAS TREATED WITH AN ANTIBIOTIC OINTMENT. THE OTHER TWO STUDENTS WERE TREATED WITH AN OTC EYE DROP. THE ETIOLOGY OF THE EYE IRRITATION IS UNKNOWN. UNUSED SAMPLES FROM THE SAME LOT WERE RETURNED AND SENT TO AN INDEPENDENT LAB. THE TEST RESULTS REVEALED THAT THE SAMPLES WERE NON-CYTOTOXIC. A ROOT CAUSE HAS NOT BEEN DETERMINED. IT IS UNKNOWN IF THE BOUFFANT CAP CAUSED OR CONTRIBUTED TO THE REPORTED SKIN AND EYE IRRITATION. HOWEVER, DUE TO THE NEED FOR MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.
Description of Event or Problem
IT WAS REPORTED THAT THREE STUDENTS DEVELOPED EYE IRRITATION AND SKIN IRRITATION ON THEIR FOREHEAD AFTER WEARING THIS CAP.