MAUDE Adverse Event Report: REPLENS VAGINAL MOISTURIZER; LUBRICANT

Lot Number U64273

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Pain (1994); Burning Sensation (2146); Reaction (2414)

Event Date 07/01/2016

Event Type  Injury  

Event Description

He and wife used product during sex three months ago after the first use he noticed some irritation in his penis.On the second day the shaft of his penis was very painful.He says he initially accused his wife of having an affair.They both were seen by doctors but were negative for sexual diseases.A doctor prescribed him metronidazole.No improvement.He was then prescribed doxycycline.No improvement.His doctor referred him to urologist but he would have to wait a long time for appointment so he saw nurse practioner.The nurse prescribed him penicillin, no improvement.Finally he saw urologist.The caller says that urologist suggested there was a chemical reaction.The urologist gave him cipro.However, he still has burning and needle-like pain in shaft of penis.He says he is very upset that the fda would allow this product on the market.He has been dealing with this problem since (b)(6).He says the ingredients in the product are causing his problem.They are attaching to the cell wall in his penis.Purified water.Glycerin, mineral oil, polycarbophil, carbomer, hydrogenated palm oil glyceride, sorbic acid, methyl paraben, sodium hydroxide.He did not see an allergist.He has not contacted the mfr.

Event Description

Additional information received on 10/11/2016 from reporter for report #: mw5065239.He stated that he already filed a report to (b)(4) about a week and a half ago.He called them to follow up on it today but was referred to cdrh.He states that on (b)(6) 2016 he engaged in intercourse with his wife.Initially he used ky jelly but discontinued use due to the pain he felt on his penis.He then switched to replens, which he describes as the "liquid from profanity." his wife accused him of having an affair.His wife denies any adverse effects from the lubricant.

• Brand Name: REPLENS VAGINAL MOISTURIZER
• Type of Device: LUBRICANT
• MDR Report Key: 6010618
• MDR Text Key: 57098597
• Report Number: MW5065239
• Device Sequence Number: 1
• Product Code: NUC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/11/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: U64273
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 91