MAUDE Adverse Event Report: UNIQUE PULL CONDOMS

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.

• Brand Name: UNIQUE PULL CONDOMS
• Type of Device: CONDOMS
• MDR Report Key: 5996447
• MDR Text Key: 56484001
• Report Number: MW5065159
• Device Sequence Number: 1
• Product Code: HIS
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 68