K-Y YOURS & MINE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-27 for K-Y YOURS & MINE manufactured by Reckitt Benckiser Healthcare Int. Limited.

Event Text Entries

[103590634] 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.
Patient Sequence No: 1, Text Type: N, H10


[103590635] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010164364-2018-00003
MDR Report Key7374456
Report SourceCONSUMER
Date Received2018-03-27
Date of Report2018-03-27
Date of Event2018-02-01
Date Mfgr Received2018-03-02
Date Added to Maude2018-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. JOANNE MARTINEZ
Manufacturer StreetDANSOM LANE
Manufacturer CityHULL, HU8 7DS
Manufacturer CountryUK
Manufacturer PostalHU8 7DS
Manufacturer G1RECKITT BENCKISER HEALTHCARE INT. LIMITED
Manufacturer StreetDANSOM LANE
Manufacturer CityHULL, HU8 7DS
Manufacturer CountryUK
Manufacturer Postal CodeHU8 7DS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameK-Y YOURS & MINE
Generic NameLUBRICANT, PERSONAL
Product CodeNUC
Date Received2018-03-27
Lot Number1556N1A
Device Expiration Date2019-09-30
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRECKITT BENCKISER HEALTHCARE INT. LIMITED
Manufacturer AddressDANSOM LANE HULL, HU8 7DS UK HU8 7DS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-27

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