MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED KY WARMING JELLY; CLASS II

Catalog Number NOT APPLICABLE

Device Problem Excessive Heating (4030)

Patient Problems Caustic/Chemical Burns (2549); Skin Burning Sensation (4540)

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 ky that was used as ky warming jelly.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 company¿s assessment is serious with relatedness of possible.

Event Description

The product caused a chemical burn on the patient's penis [chemical burn of genitalia].The product started heating up burned the patient's penis [penile burning sensation].Case narrative: initial report.Received date 22-mar-2022.Received from consumer relations.Country united states.Reference no: (b)(4).Udi reference no: (b)(4).Medical device: ky warming lubricant jelly.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 of unknown age.It was reported that on an unknown date, a male patient of unknown age used ky warming lubricant jelly.The patient stated that the product caused a chemical burn on his penis for several months.Because of this, he had surgery to remove his foreskin.Within 5 seconds of sex, the product started heating up and burning the penis.Medical history: the patient had surgery to remove his foreskin.Three failed follow up attempts with the consumer have been made.The consumer failed to provide further information or product sample.The case was deemed serious due to a condition necessitating medical or surgical intervention to prevent serious deterioration in health.The relatedness was deemed as unlikely because of no mechanism of action.Follow up has been requested to obtain further information.Case assessment for ky warming lubricant jelly 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 unlikely and unanticipated.Case outcome: not recovered / not resolved.

• Brand Name: KY 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: 14140187
• MDR Text Key: 289491866
• Report Number: 3008264702-2022-00001
• 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
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male