MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT. LIMITED KY JELLY PERSONAL LUBRICANT

Lot Number A0015C

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

Patient Problems Unspecified Infection (1930); Pain (1994); Dysuria (2684)

Event Date 12/25/2015

Event Type  Injury  

Manufacturer Narrative

The consumer agreed to return sample but has not.A sample from the same batch# from which the consumer's product was derived was tested and was found to be within specifications.(b)(6) consent was obtained and release was sent to consumer, but has not been returned to (b)(4) to date.No medical records available.

Event Description

Kidney infection [kidney infection].Kidney pain [renal pain].Patient could not urinate without feeling pain on lower back sides [dysuria].Case description: report no 1, received date: 04-feb-2016.Received from consumer relations, country: united states, reference no: (b)(4).Suspect product: ky jelly lubrication unspecified.Case reference number us-(b)(6) is a spontaneous case report sent by a consumer which refers to an unknown female patient.It was reported that about 3 months ago on ??-???-2015 a patient of an unknown age started using ky jelly lubrication unspecified, frequency, route, indication, stop date and duration were all unknown.She said that she had no irritation or discomfort while using the product.A week later on ??-???-2015 was rushed to the hospital because of a severe kidney infection.She was fine about two weeks after.She started using the product again because she did not see the link between her medical issue and the product.Once again rushed to the hospital with another kidney infection and this time the symptoms were much worst.She then searched for what could have caused this condition, until they talked to a medical professional about the effects of glycerine in the vaginal canal.She was told that the substance found in the product, turns into sugar in the body which could make its way in the urethra and cause severe complications.She reported that she has now stopped using the product and the infection had not re-occurred but felt that her kidneys were damaged permanently, for which they could not urinate without feeling pain on her lower back sides.She continued to suffer at the time of reporting.She also added that she could provide hospital documents on demand.The outcome of the case was not recovered at the time of reporting.Ky jelly lubrication unspecified was dechallenged and the event [?]kidney infection' was resolved whereas the event [?]patient could not urinate without feeling pain on lower back sides' persisted.No further information was available at the time of report.Case assessment for ky jelly lubrication unspecified is as follows: the reported serious assessment has not been provided, case relatedness is possible the company's assessment is non serious with a relatedness of possible and unknown.Case outcome: not recovered / not resolved.Report no 2, received date: 11-feb-2016.Received from consumer relations, country: (b)(6), reference no: (b)(6).Information added / updated: country: updated from "united states" to "(b)(4)".Lot number: "a0015c" was added.Age of the patient: "(b)(6) years" was added.Product start date: updated from "??-???-2015" to "??-(b)(6)-2015".Product last date: "(b)(6) 2015" was added.Date of event onset: "(b)(6) 2015" was added.Event: "kidney pain" was added.Qc result "batch investigation was within specifications" was added.Patient stated that she began using ky personal lubricant in (b)(6) of 2015.She said that she had used this product 2-3 times per week.She stated that she had last used this product on (b)(6) 2015.She stated that on (b)(6) 2015, she began to experience severe kidney pains.She stated that she was taken to the hospital via ambulance.She stated that she was admitted to the hospital for 2 days and was diagnosed with a kidney infection.Patient stated that she was treated intravenously with antibiotics, and was sent home with a prescription for oral antibiotics.She stated that although the kidney infection has resolved, she still experiences lower back pain when she urinates.Treatment: iv antibiotics in hospital and oral antibiotics for home.The patient was admitted to hospital, admittance date ??-(b)(6) 2015, discharge date ??-(b)(6) 2015 and 2 days.The case was deemed serious due to hospitalization.No further information was available at the time of report.Follow up has been requested to obtain further information.Case assessment for ky personal lubricant is as follows: the reported serious assessment has not been provided, case relatedness is possible.The reported serious assessment is serious; case relatedness is possible and unlisted.Case outcome: not recovered / not resolved.On (b)(6) 2018: review of historic cases completed by (b)(6) safety physician.Case upgraded to serious and reported.Case comment: diagnosis: kidney infection.

• Brand Name: KY JELLY PERSONAL LUBRICANT
• Type of Device: PERSONAL LUBRICANT
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lane; hull, HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 7820445
• MDR Text Key: 118389909
• Report Number: 9610643-2018-00009
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• PMA/PMN Number: K810310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: A0015C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR