MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE (UK) LTD. K-Y LIQUID; CLASS II

Model Number NOT APPLICABLE

Device Problem Insufficient Information (3190)

Patient Problems Depression (2361); Caustic/Chemical Burns (2549); Blister (4537)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6) has received the product information (batch number and expiry date) from the reporter and has instigated an internal factory investigation.Upon reporting the incident, the reporter was able to provide details of the product name, batch number and expiry date therefore enabling reckitt 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 company's assessment was serious with a relatedness of possible.

Event Description

Patient experienced chemical burns on penis and testicles [chemical burn of genitalia] patient was depressed that he could not have sex and missing time at work [depression] product caused patient's penis to break out in blisters all over the shaft [penile blister] case narrative: initial report.Received date 26-oct-2022.Received from consumer relations.Country united states.Reference no: (b)(4).Medical device: k-y liquid lubricant.Batch number: 2068ee1.Expiry date: 31-dec-2022.Case reference number (b)(4) is a spontaneous case report sent by a consumer, which refers to a male patient of unknown age.It was reported by the patient's partner that on (b)(6) 2022, a male patient of unknown age used k-y liquid lubricant for intercourse, stop date on (b)(6) 2022.The reporter stated that the product caused their boyfriend's penis to break out in blisters all over the shaft.They stated that their boyfriend had not used the product since.They stated that their boyfriend had not gone to the doctor yet however, planned to visit doctor shortly.The reporter provided the batch number and expiry date; however no further information was provided related to batch investigation.Follow up has been requested to obtain further information.Case assessment for k-y liquid lubricant is as follows: the reporting consumer¿s serious assessment has not been provided, case relatedness is possible.The company's assessment is non-serious with a relatedness of possible and unanticipated.Case outcome: not recovered / not resolved.Report no.2 received date 03-nov-2022.Received from consumer relations.Country united states.Reference no: (b)(4).Information added/ updated: udi reference: (b)(4).Case upgraded from non-serious to serious.Seriousness criteria hospitalization and medically significant were added.Hospitalization start date: ¿??-???-2022¿ added.Event: "chemical burn of penis" and "depressed state" added.Reporter's diagnosis: "chemical burn of genitalia" added.Emergency room visit checked.Preliminary comment was updated.Factory investigation reference: "(b)(4)" added.Company diagnosis/syndrome: updated from "penile blister" to "chemical burn of genitalia".The reporter stated that her boyfriend experienced chemical burns on his penis and testicles.The reporter stated that her boyfriend never saw their healthcare professional but ended up in the emergency room (er).She stated that her boyfriend was diagnosed with chemical burns on his penis and testicles.She stated that her boyfriend was admitted to the hospital (??-???-2022) and was still there at the time of the reporting.She stated that she did not know the treatment that was given to him.She reported that her boyfriend was depressed that he could not have sex and was missing time at work.She stated that it was the first time that the product was used.The reporter provided the batch number and expiry date; reckitt has instigated a factory investigation using this information.The patient was admitted to hospital, admittance date ??-???-2022, discharge date and days in hospital were all unknown.The case was deemed serious because it was classed as medically significant due to depression and hospitalization.The relatedness was deemed as possible as it occurred after use.Follow up has been requested to obtain further information.Case assessment for k-y liquid lubricant is as follows: the reporting consumer¿s serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: not recovered / not resolved.Case comments: reporter's diagnosis: "chemical burn of genitalia".

• Brand Name: K-Y LIQUID
• Type of Device: CLASS II
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE (UK) LTD.
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: 0148232615
• MDR Report Key: 15892060
• MDR Text Key: 308089468
• Report Number: 3002807985-2022-00002
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 2068EE1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• 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; Other
• Patient Sex: Male