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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNIQUE PULL CONDOMS

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UNIQUE PULL CONDOMS Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Skin Irritation (2076); Swelling (2091)
Event Date 09/16/2016
Event Type  malfunction  
Event Description
Got some unique pull condoms from (b)(4) and after using them, noticed a redness and swelling. Problems went away after about an hour and having washed the area thoroughly. After this incident, i went online to investigate the brand and discovered that it isn't fda approved for sale in the us. In fact, i found out that (b)(4) actually sells a number of non-fda approved condoms. Is this legal? isn't there a federal law regarding the sale of non-fda approved terms to the public? please investigate this company. While it may seem like a minor thing, condoms by design interact with the human body in a very intimate way. Issues of safety regarding these items should be high. If i had known this condoms weren't fda approved! i certainly wouldn't purchased these nor used them.
 
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Brand NameUNIQUE PULL CONDOMS
Type of DeviceCONDOMS
MDR Report Key5996447
MDR Text Key56484001
Report NumberMW5065159
Device Sequence Number1
Product Code HIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 10/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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