MAUDE Adverse Event Report: LIL' DRUG STORE PRODUCTS, INC. PLASTIC APPLICATOR OF REPLENS VAGINAL MOISTURIZER ; LUBRICANT

Model Number NONE

Device Problem Material Integrity Problem (2978)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Inflammation (1932)

Event Date 09/07/2015

Event Type  Injury  

Event Description

The one reusable plastic applicator of replens vaginal moisturizer for 14 applications is very sharp.It does not have threads so that adds to the sharpness when the medication is dispensed to the tube.I started using the product on (b)(6) 2015.The applicator caused bad bleeding of the vaginal tissues.I had fever the following day.I had inflamed vaginal tissue.I read bad reviews about the sharp applicator but nothing is done about it.The product itself is good but the sharp applicator has to be changed.I submitted a comment to church and dwight consumer relations department.Informed them that i will contact the fda about the sharp applicator.Here is the auto-reply i received: "thank you for taking the time to contact us about replens vaginal moisturizer.Although we cannot guarantee an immediate response, we will replay as soon as possible.If you need immediate assistance, please call us at (b)(4).Our consumer relations department is available monday - friday from 9:00 am until 5:00 pm eastern time".I am a chemist in the drug delivery systems division of (b)(6) so i know how the fda takes complaints seriously.This is an over-the-counter medication.The consumers may not have help about reporting the sharp applicator used with the medication.So i have to speak up for the ones who had given reviews about the bad applicator.I was hurt so i am taking this seriously.

• Brand Name: PLASTIC APPLICATOR OF REPLENS VAGINAL MOISTURIZER
• Type of Device: LUBRICANT
• Manufacturer (Section D): LIL' DRUG STORE PRODUCTS, INC.
• MDR Report Key: 5148003
• MDR Text Key: 28352593
• Report Number: MW5056943
• 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
• Report Date: 09/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: NONE
• Device Catalogue Number: NONE
• Device Lot Number: UF5118
• Other Device ID Number: 366715830357
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 54