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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. E-Z LUBRICANTING JELLY; LUBRICANT, PATIENT
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MEDLINE INDUSTRIES, INC. E-Z LUBRICANTING JELLY; LUBRICANT, PATIENT Back to Search Results
Catalog Number MDS032290
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Burning Sensation (2146)
Event Date 05/23/2018
Event Type  malfunction  
Event Description
Patient was undergoing pelvic exam by dr.Patient has been treated with prior radiation therapy to the vulva for vulvar cancer.Dr.Applied e-z lubricant to the vulva for the examination and the patient immediately began experiencing intense burning.Patient was given wipes to clean the skin and a peri bottle was obtained from distribution.Patient stated the burning sensation was gone after having thoroughly cleaned herself.
 
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Brand Name
E-Z LUBRICANTING JELLY
Type of Device
LUBRICANT, PATIENT
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key7582230
MDR Text Key110485354
Report Number7582230
Device Sequence Number1
Product Code KMJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date12/31/2020
Device Catalogue NumberMDS032290
Device Lot Number8A078
Other Device ID NumberRA16HND
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/29/2018
Event Location Other
Date Report to Manufacturer05/29/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; OTHER, REMOVAL OF THE LUBRICANT PRODUCT FROM THE
Patient Age49 YR
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