CRI1004Z

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for CRI1004Z manufactured by Medline Industries, Inc..

Event Text Entries

[41417071] 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.
Patient Sequence No: 1, Text Type: N, H10


[41417072] It was reported that three students developed eye irritation and skin irritation on their forehead after wearing this cap.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2016-00025
MDR Report Key5532195
Date Received2016-03-29
Date of Report2016-03-29
Date Mfgr Received2016-03-01
Device Manufacturer Date2015-06-01
Date Added to Maude2016-03-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDIANE CHRISTENSEN
Manufacturer StreetONE MEDLINE PLACE
Manufacturer CityMUNDELEIN IL 60060
Manufacturer CountryUS
Manufacturer Postal60060
Manufacturer Phone8476434747
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameBOUFFANT CAP
Product CodeFYF
Date Received2016-03-29
Catalog NumberCRI1004Z
Lot Number26315060024
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-03-29

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