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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE MEDLINE SENSICARE GLOVES

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MEDLINE MEDLINE SENSICARE GLOVES Back to Search Results
Model Number MSG1070
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2017
Event Type  malfunction  
Event Description
Technician opened medline sensicare gloves size 7 and discovered them to have brown spotting on left hand. Item# msg1070, lot# 703934540470-5. Complaint reference# (b)(4).
 
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Brand NameMEDLINE
Type of DeviceSENSICARE GLOVES
Manufacturer (Section D)
MEDLINE
MDR Report Key6851355
MDR Text Key85606583
Report NumberMW5072023
Device Sequence Number1
Product Code LZC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberMSG1070
Device Lot Number703934540470-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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