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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. E-Z LUBRICATING JELLY; LUBRICANT, PATIENT
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MEDLINE INDUSTRIES, INC. E-Z LUBRICATING JELLY; LUBRICANT, PATIENT Back to Search Results
Catalog Number MDS032290
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2018
Event Type  malfunction  
Event Description
I went through the results in basket and processed pap smear results, finding 7 pap smears which returned with no diagnosis and/or scant cellularity.This was an unusually high number of no diagnosis pap smears, as we typically have 1 or 2 in a month.I sent them over to the respective providers.Dr.Called me back and said something was wrong for there to be that many with no diagnosis.Dr.Said he spoke with pathology and that they agreed to re-review the pap smears.
 
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Brand Name
E-Z LUBRICATING JELLY
Type of Device
LUBRICANT, PATIENT
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key7582181
MDR Text Key110486757
Report Number7582181
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 AND 71042
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
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, POSSIBLY REPEAT PAP SMEARS
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