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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALWAYS INFINITY REGULAR UNSCENTED PAD WITH WINGS
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ALWAYS INFINITY REGULAR UNSCENTED PAD WITH WINGS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Local Reaction (2035); Swelling (2091); Skin Inflammation (2443)
Event Date 07/20/2015
Event Type  Injury  
Event Description
I used always unscented infinity regular pads with wings that i bought at (b)(6).I used one from this new package and had a severe skin reaction to the product.The skin on my labia and buttocks became red, raised, and inflamed.The area became very itchy and my skin started coming off.I had changed the pad three times that day, and doing so did not alleviate any symptom.I returned the product and went to whole foods to purchase 100% organic cotton pads and tampons to try to minimize further irritation.The pain and itchiness stopped with this change.The entire first layer of my skin is gone and raw, and i have a rash that extends to my buttocks where the pad touched my skin.The swelling is gone but the skin is peeling off.The ingredients and parts of pads should be regulated to avoid dangerous reactions.My research into the issue indicates that other women have had issues with this product injuring their genitals.
 
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Brand Name
INFINITY REGULAR UNSCENTED PAD WITH WINGS
Type of Device
INFINITY REGULAR UNSCENTED PAD WITH WINGS
Manufacturer (Section D)
ALWAYS
MDR Report Key4945839
MDR Text Key6257899
Report NumberMW5044790
Device Sequence Number1
Product Code HHD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/21/2015
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age27 YR
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