KROGER FRAGRANCE FREE BABY WIPES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-09 for KROGER FRAGRANCE FREE BABY WIPES manufactured by The Kroger Co..

Event Text Entries

[17150662] Gentle persons: i am a (b)(6) man with, among other problems, hemorrhoids. Last (b)(6) (2012), my doctor ((b)(6)) suggested that after a bowel movement, i use wet toilet paper. That proved messy, so i began using kroger fragrance free baby wipes. They worked really well. Except something was happening that i couldn't see. I developed an intertrigo condition, a deep lesion (right above my anus that exuded pus and sometimes blood. I purchased a sitz bath tub and tried soaking the site daily in warm salt water, but there was no improvement. Finally, i returned to dr. (b)(6) on (b)(6) 2013. He suggested continuing the sitz baths and covering the area with a hydrocolloid patch (at about (b)(4) - lasting 1-1/2 days! ) if there was not improvement over two weeks, he referred me to (b)(6) dermatology in (b)(6). I had the embarrassing task of asking my wife to inspect the area. I continued using the wipes. There was some small improvement, but still exuding pus and blood, so i made the (b)(6) dermatology appointment for (b)(6), with dr. (b)(6). Dr. (b)(6) asked if i used wet wipes, and told me that he has seen a number of cases with similar symptoms as a result of the wipes. He thought it might be the preservatives used in the products. He discontinued use of the hydrocolloid patches and prescribed both hydrocortisone and anti-fungal ointments, and a medicated powder. I discontinued use of the wipes immediately. My condition is clearing up quite slowly, and still causes me discomfort. I have spent at least (b)(4) on coccyx cushions, hydrocolloid patches, and medications because of your product. My portion of the doctor bill has not arrived yet. The only warning on the product itself is the danger of suffocation from the bag, and nothing about side effects from the ingredients. I think (b)(4) should do something to make me whole and should either discontinue sale of the product or else post warnings about possible side effects. I note from online research that mine is not the only case of negative reactions to wet wipes. I am therefore ccing this letter to the u. S. Food and drug administration. (b)(4)
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5030844
MDR Report Key3224271
Date Received2013-07-09
Date of Report2013-06-01
Date of Event2012-06-01
Date Added to Maude2013-07-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKROGER FRAGRANCE FREE BABY WIPES
Generic NameBABY WIPES
Product CodeLDQ
Date Received2013-07-09
Device Sequence No1
Device Event Key0
ManufacturerTHE KROGER CO.
Manufacturer Address1014 VINE ST CINCINNATI OH 45202110 US 45202 1100


Patients

Patient NumberTreatmentOutcomeDate
10 2013-07-09

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