MAUDE Adverse Event Report: HENRY SCHEIN, INC. LUBRICATING JELLY; LUBRICANT, PATIENT

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)

Event Date 08/08/2018

Event Type  Injury  

Event Description

Reporter states that on (b)(6) 2018 she had a pap smear at her physician's office and had a very severe reaction to the lubrication used.Patient has a hx of vulvodynia and believes this event has caused a flareup.She goes on to say that these flareups feel like her "whole body is on fire" and could last years.She had to quit her job and is unsure what to do.

• Brand Name: LUBRICATING JELLY
• Type of Device: LUBRICANT, PATIENT
• Manufacturer (Section D): HENRY SCHEIN, INC.
• MDR Report Key: 7805571
• MDR Text Key: 118015974
• Report Number: MW5079298
• Device Sequence Number: 1
• Product Code: KMJ
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR