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

Lot Number	1556N1A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional 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 consumer 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 persons sensitive to menthol.If irritation or discomfort occurs, discontinue use and consult your health care provider.The company's assessment is serious with a relatedness of possible.
Event or Problem Description
Urinary tract infection [urinary tract infection].While urination there was just a drip or two or nothing at all [urinary retention].Feeling like patient had to go to urinate [micturition urgency] bladder infection [cystitis].Burning while urinating [dysuria].Case description: report no 1, received date: 02-mar-2018.Received from consumer relations, country: united states, (b)(4).Suspect product: ky yours and mine lubricant.Batch no: 1556n1a.Expiry date: 30-sep-2019.(b)(4) is a spontaneous case report sent by an consumer which refers to a female (b)(6).It was reported by patient's boyfriend that on an unspecified date in (b)(6) 2018; his (b)(6) girlfriend started using ky yours and mine lubricant, frequency twice, stop date (b)(6) 2018, route, indication and duration were all unknown.Reporter stated that his girlfriend started using the k-y yours and mine lubricant for the first time 3 weeks before reporting and 3 days after using his girlfriend began to experience burning while urinating and always feeling like she had to go but, when she tried to urinate there was just a drip or two or nothing at all.Reporter stated that she went to the doctor and was treated for a bladder infection.He then stated that the patient tried the k-y yours and mine again about 6 days before reporting and 4 days later she began having the same symptoms.He stated that she spoke with her doctor again and was currently taking the medication her doctor prescribed her.He stated that his girlfriend was on a second round of antibiotics for a urinary tract infection which she had each time they used the product.Patient was feeling much better at the time of reporting.She had no history of urinary tract infections in the past.Patient liked the sensation of the product but, could not use it again due to urinary tract infections.At the time of the report the outcome of the effect was recovering.K-y yours and mine lubricant was de-challenged.K-y yours and mine lubricant was subsequently re-introduced and adverse events reoccurred.The case was deemed serious because it was classed as medically significant due to urinary retention.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 is serious with a relatedness of possible and unlisted.Case outcome: recovering / resolving.Case status: ongoing.

• Brand Name: K-Y YOURS & MINE
• Common Device Name: LUBRICANT, PERSONAL
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• MDR Report Key: 7374456
• Report Number: 3010164364-2018-00003
• Device Sequence Number: 1170938
• Product Code: NUC
• UDI-Device Identifier: 67981088922
• UDI-Public: 67981088922
• Combination Product (Y/N): N
• PMA/510(K) Number: K072421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Lot Number: 1556N1A
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR