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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH ESTEEM STRETCHY NITRILE GLOVES

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CARDINAL HEALTH ESTEEM STRETCHY NITRILE GLOVES Back to Search Results
Catalog Number 8816NB
Device Problem Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2017
Event Type  malfunction  
Event Description
New gloves repeatedly ripping when taken out of box and worn. Staff report several similar incidents related to this brand of glove. Ripped gloves are discarded. New gloves are utilized. No reports of patient or staff harm as a result of the weak gloves have been made. Specific patient not applicable.
 
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Brand NameESTEEM
Type of DeviceSTRETCHY NITRILE GLOVES
Manufacturer (Section D)
CARDINAL HEALTH
mcgaw park IL 60085
MDR Report Key7100903
MDR Text Key94408954
Report NumberMW5073845
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
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8816NB
Device Lot Number7F17D508
Was Device Available for Evaluation? No
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? No
Type of Device Usage

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