MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-01 for UNIQUE PULL CONDOMS manufactured by Unk.
[56484001]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065159 |
| MDR Report Key | 5996447 |
| Date Received | 2016-10-01 |
| Date of Report | 2016-10-01 |
| Date of Event | 2016-09-16 |
| Date Added to Maude | 2016-10-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNIQUE PULL CONDOMS |
| Generic Name | CONDOMS |
| Product Code | HIS |
| Date Received | 2016-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-01 |