MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED K-Y WARMING JELLY; CLASS II

Model Number NOT APPLICABLE

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

Patient Problem Caustic/Chemical Burns (2549)

Event Type  Injury  

Manufacturer Narrative

No action is considered necessary for this incident at this point, reckitt is currently waiting for follow up information regarding the reported incident.The patient did specify the variety of k-y that was used as k-y warming gel.The patient neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.Further information is expected.The product labelling stated that, ¿avoid use it pregnant, breastfeeding or in case of vaginal infection unless prescribed by your doctor.Keep out of reach of children.Avoid contact with the eyes.This product is not a contraceptive and does not contain a spermicide.K-y lubricants may slow sperm down, so it you are trying to have a baby, talk to your doctor prior use.Use as directed lf you¿re experiencing persistent vaginal dryness, stop use and ask a doctor.In case of vaginal infection, please consult your doctor before use.This package is tamper evident.Do not use if quality seal on the opening of the tube is missing or broken.Slippery, avoid spills.Store in a cool dry place away from direct sunlight¿.The company's assessment is serious with a relatedness of possible.

Event Description

Chemical burn / product burned patient's foreskin [chemical burn of genitalia].Case narrative: initial report.Received date 02-jan-2022.Received from consumer relations.Country united states.Reference no: (b)(4).Medical device: k-y warming gel.Batch number and expiry date: not provided.Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a male patient aged (b)(6) years.It was reported that on an unknown date, a (b)(6) -year-old male patient used k-y warming gel.Patient stated that he had an issue with k-y warming gel.It burned his foreskin and it caused a chemical burn.He could not have sex and he had surgery to take off his foreskin.Medical history: procedure: patient was having surgery to take off his foreskin.The case was deemed serious due to a condition necessitating medical or surgical intervention to prevent serious deterioration in health.Follow up has been requested to obtain further information.Case assessment for k-y warming gel 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.

Manufacturer Narrative

No action is considered necessary for this incident at this point, reckitt is currently waiting for follow up information regarding the reported incident.The patient did specify the variety of k-y that was used as k-y warming gel.The patient neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.Further information is expected.The product labelling stated that, ¿avoid use it pregnant, breastfeeding or in case of vaginal infection unless prescribed by your doctor.Keep out of reach of children.Avoid contact with the eyes.This product is not a contraceptive and does not contain a spermicide.K-y lubricants may slow sperm down, so it you are trying to have a baby, talk to your doctor prior use.Use as directed lf you¿re experiencing persistent vaginal dryness, stop use and ask a doctor.In case of vaginal infection, please consult your doctor before use.This package is tamper evident.Do not use if quality seal on the opening of the tube is missing or broken.Slippery, avoid spills.Store in a cool dry place away from direct sunlight¿.The company's assessment is serious with a relatedness of possible.

Event Description

Chemical burn / product burned patient's foreskin [chemical burn of genitalia].Case narrative: initial report.Received date 02-jan-2022.Received from consumer relations.Country(b)(6).Reference no: (b)(4).Medical device: k-y warming gel.Batch number and expiry date: not provided.Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a male patient aged 28 years.It was reported that on an unknown date, a 28-year-old male patient used k-y warming gel.Patient stated that he had an issue with k-y warming gel.It burned his foreskin and it caused a chemical burn.He could not have sex and he had surgery to take off his foreskin.Medical history: procedure: patient was having surgery to take off his foreskin.The case was deemed serious due to a condition necessitating medical or surgical intervention to prevent serious deterioration in health.Follow up has been requested to obtain further information.Case assessment for k-y warming gel 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.Final report.Received date 25-feb-2022.Received from dso.Country(b)(6).Reference no: (b)(4).Rb attempted to make further contact with the patient, but they called from a toll-free line.They did not provide us with any contact details to allow us to gather any further information.The patient did not provide the batch number or expiry date associated with the product; therefore, it has not been possible for rb to conduct any further investigation nor retrieve quality assurance data for the specific batch manufactured.In 2019, (b)(4) units were produced for sale in the united states, (b)(4) units in the eea and (b)(4) units in the rest of the world, and 0 similar incidents were reported worldwide.In 2020,(b)(4) units were produced for sale in the united states, (b)(4) units in the eea and (b)(4) units in the rest of the world, and 0 similar incidents were reported worldwide.In 2021, (b)(4) units were produced for sale in the united states, (b)(4) units in the eea and (b)(4) units in the rest of the world, and 0 similar incident were reported worldwide.In 2022, (b)(4) units were produced for sale in the united states, (b)(4) units in the eea and (b)(4) units in the rest of the world, and 0 similar incidents were reported worldwide.The case was deemed serious due to a condition necessitating medical or surgical intervention to prevent serious deterioration in health.Case assessment for k-y warming gel 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.

• Brand Name: K-Y WARMING JELLY
• Type of Device: CLASS II
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: 0148232615
• MDR Report Key: 13511924
• MDR Text Key: 285453544
• Report Number: 3002807985-2022-00001
• Device Sequence Number: 1
• Product Code: NUC
• 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,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male