NONE 54018E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-05 for NONE 54018E manufactured by .

Event Text Entries

[2488634] I placed an order for a set of ice bags and a set of egg cookers from (b)(6). Item info follows: ice bags - code tqt1, item number (b)(4). Egg cookers - code sy04, item number (b)(4). When i opened the box, the odor was so overwhelming that i almost fainted. I thought perhaps there was a coating on the bags and decided to immerse them in soapy water and dry them. The odor has not dissipated at all and to be frank, i'm afraid to handle the product now due to the strong, pungent odor coming from the bags. I do plan to contact (b)(6) and return the items, but somebody should be regulating these products for safety before entering the united states. I am convinced that these bags contain some harmful chemical that would definitely not pass united states standards for health and safety! Thank you for your attention to this email. I plan to contact (b)(6) tomorrow and will return both products. (b)(6). Product is a set of 3 ice bags in graduated sizes. Large being about 10", medium about 8" and smallest about 5". Colors are green & white, brown & white, and pink & white. Ice is inserted into the bags and the tops are then screwed on. Product category: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5024308
MDR Report Key2465601
Date Received2012-02-05
Date of Report2012-02-05
Date of Event2012-01-22
Date Added to Maude2012-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNONE
Generic NameICE BAG
Product CodeKYR
Date Received2012-02-05
Catalog Number54018E
Device AvailabilityY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2012-02-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.