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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATURE'S PLACE HYPOALLERGENIC WIPES SENSITIVE; FEMININE WIPE
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NATURE'S PLACE HYPOALLERGENIC WIPES SENSITIVE; FEMININE WIPE Back to Search Results
Lot Number 160928MO
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Swelling (2091)
Event Date 07/31/2017
Event Type  Injury  
Event Description
Purchased nature's place hypoallergenic sensitive wipes on (b)(6) 2017.I used them for three days and started breaking out in an itchy rash which very quickly spread.I initially thought perhaps i had been stung by an insect, but when it started spreading so quickly i went to my doctor.He gave me a prednisone shot and told me to take benadryl when i got home.After taking two benadryl at a time every 8 hours, i still kept breaking out.I finally realized my labia were horribly swollen and that is where the problem originated.When i stopped using the wipes,the condition cleared up."is the product over-the-counter: yes, frequency: 4 times a day, how was it taken or used: topical, dates of use: (b)(6) 2017 - (b)(6) 2017, did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Vaginal wipe after urination.".
 
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Brand Name
NATURE'S PLACE HYPOALLERGENIC WIPES SENSITIVE
Type of Device
FEMININE WIPE
MDR Report Key6785234
MDR Text Key82534117
Report NumberMW5071490
Device Sequence Number1
Product Code NEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date04/01/2019
Device Lot Number160928MO
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight56
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