PRESEED PERSONAL LUBTICANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for PRESEED PERSONAL LUBTICANT manufactured by Church And Dwight.

Event Text Entries

[107078631] I used "preseed" lubricant for the first time, and within hours had pain in my uterus, sharp twinges. The pain migrated to both sides of my lower abdomen and stayed, a burning, constant ache with intermittent sharp twinges across entire abdomen. Went to walk in clinic, they ran an urinalysis and it came back negative for problems. Days later, much worse, overall unwell feeling, pain down groin, pain in left shoulder, swollen glands under chin. Did feel a little better after about 5 days. Had no idea it could have been the lube that caused this, so when my husband was back on the weekend, used the lube again. Issues after this use much worse, the product had contact with my mouth and my entire throat swelled up, went to er, had ct scan of abdomen, they still can't find what is wrong with me. Severe pain, had morphine, but the er can't help me, they say followup with gynecology. By this time i felt i might not survive and suspected the lubricant. Went to other health care providers. Finally weeks later got in to county health department. The np there found bacteria in my vaginal/ cervical swab and i got put on an antibiotic. Severe pains and general unwell feeling ongoing. After all that time, as far as we can tell is there was irritation from some type of allergic reaction to preseed, and an upper reproductive tract infection. I had to have a 2nd antibiotic, and by the second day on that i felt a little better. Dr says the ingredients of preseed can be very irritating and are carcinogens including parabens and sodium hydroxide (lye). Overall i lost track of how many providers i saw. I was in 3 different hospitals, 2 urgent cares, 3 gynecologists, county health and more. I would like a professional lab to analyzer the content of the lubricant. I filed a complaint with the company that makes preseed and was sent an envelope to mail back the product, but i did not. Why was the person using the product: as an intimacy aid.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5076804
MDR Report Key7467771
Date Received2018-04-26
Date of Report2018-04-12
Date Added to Maude2018-04-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePRESEED PERSONAL LUBTICANT
Generic NameLUBRICANT, PERSONAL
Product CodeNUC
Date Received2018-04-26
Device Expiration Date2019-02-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCHURCH AND DWIGHT


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-26

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