MAUDE Adverse Event Report: RECKITT BENCKISER K-Y YOURS & MINE; LUBRICANT, PERSONAL

Lot Number 450G1A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fever (1858); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330)

Event Date 11/12/2016

Event Type  Injury  

Manufacturer Narrative

Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident.Upon reporting the incident, the reporter was able to provide details of the product name, batch number and expiry date, therefore enabling rb to review the process records and release testing results from the point of initial manufacture and check retained samples for the specific batch identified.The product labelling also states that "this product contains ingredients that may cause skin irritation, especially in person sensitive to menthol.If irritation or discomfort occurs, discontinue use and consult doctor.This product is not a contraceptive and does not contain a spermicide.Keep out of reach of children".The company's assessment is serious with a relatedness of possible.

Event Description

Case description: report no 1, received date: 15-nov-2016.Received from consumer relations, country: united states, reference no: (b)(4).Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a female aged (b)(6) years.It was reported by patient's partner that on (b)(6) 2016, his (b)(6) year old female partner used k-y yours and mine lubricant, frequency single, stop date (b)(6) 2016 and duration was 1 day.He said patient started to experience vaginal pain and discomfort ((b)(6) 2016) which she ended up seeking medical attention.She went to the urgent care on saturday (b)(6) 2016, and the physician stated there was a foreign bacterial infection and the product was the cause of the vaginal pain and discomfort.She had to get culture tested for evaluation.On (b)(6) 2016 she went back to her doctor and they gave her antibiotics due to her having a slight fever.The doctor stated it could also be a possible urinary tract infection with a kidney infection.She was not admitted to hospital.At the time of reporting, action taken with product was withdrawn and case outcome was not recovered.At the time of the report, the effects was ongoing and patient had visited the physician.It was unknown if the patient has any relevant underlying conditions or medical history.The case was deemed serious because it was classed as temporary or permanent functional incapacity and medically significant due to kidney infection, pyrexia, urinary tract infection.No further information was available at the time of report.Case assessment for k-y yours and mine lubricant is as follows: the reported serious assessment has not been provided, case relatedness is possible the company's assessment for the case is serious with a relatedness of possible and unlisted.Case outcome: not recovered/not resolved-ongoing.Case status: ongoing.

• Brand Name: K-Y YOURS & MINE
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): RECKITT BENCKISER; 399 interpace parkway; parsippany NJ 07054
• Manufacturer (Section G): RECKITT BENCKISER; 399 interpace parkway; parsippany NJ 07054
• Manufacturer Contact: joanne martinez ; dansom lane; hull, hull HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 6140145
• MDR Text Key: 61291002
• Report Number: 3010164364-2016-00004
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• PMA/PMN Number: K072421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Lot Number: 450G1A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR