MAUDE Adverse Event Report: RB HEALTH (US) LLC K-Y NATURAL FEELING PERSONAL LUBRICANT WITH HYALURONIC ACID, 3.38 FL O; LUBRICANT, PERSONAL

Lot Number 1281JJ4

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Discoloration (2074); Localized Skin Lesion (4542); Swelling/ Edema (4577)

Event Date 05/10/2022

Event Type  Injury  

Event Description

Rapid allergic reaction; at 10pm on (b)(6) 2022, i opened a factory sealed undamaged container of k-y natural feeling personal lubricant with hyaluronic acid, 3.38 fl oz acquired from (b)(6).The foil seal containing product fell onto the top of my right index finger on the distal joint.Within one minute the area began to swell forming two deep blister like lesions with generalized edema.I washed extensively and the swelling did not spread further.There was no pain or pruritis associated with the swelling.No additional symptoms were noted; 12 hours later the two non adherent deep blister lesions persist with minor pruritis and rubor.I do not have a history of anaphylaxis or significant allergic reactions.I suspect this was caused by the sodium hyaluronate component as i have not had issues with products containing the other components (water, glycerin, propanediol, xanthan gum, benzoic acid, sodium hyaluronate, lactate and lactic acid).I am not aware of any prior exposure to sodium hyaluronate in the past.I am not currently experiencing any illness.

• Brand Name: K-Y NATURAL FEELING PERSONAL LUBRICANT WITH HYALURONIC ACID, 3.38 FL O
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): RB HEALTH (US) LLC; parsippany NJ
• MDR Report Key: 14408018
• MDR Text Key: 291834708
• Report Number: MW5109696
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/28/2023
• Device Lot Number: 1281JJ4
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; HYDROCHLOROTHIAZIDE/LISINOPRIL; PANTOPRAZOLE; VITAMIN D SUPPLEMENT
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White