MAUDE Adverse Event Report: CHURCH AND DWIGHT PRESEED PERSONAL LUBTICANT; LUBRICANT, PERSONAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Irritation (1941); Pain (1994); Swollen Glands (2092); Burning Sensation (2146); Reaction (2414)

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: PRESEED PERSONAL LUBTICANT
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): CHURCH AND DWIGHT
• MDR Report Key: 7467771
• MDR Text Key: 107078631
• Report Number: MW5076804
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 72