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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH, INC. HALYARD STERLING SPECIALTY -TESTED FOR USE WITH CHEMOTHERAPY - PATIENT EXAMINATION GLOVE

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HALYARD HEALTH, INC. HALYARD STERLING SPECIALTY -TESTED FOR USE WITH CHEMOTHERAPY - PATIENT EXAMINATION GLOVE Back to Search Results
Catalog Number 50706
Device Problems Hole In Material (1293); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2017
Event Type  malfunction  
Event Description
Halyard sterling nitrile powder free exam gloves, size small, ref 50706 have visible 'weak' areas on one or more fingers of the gloves. Not every glove is affected although a majority of random gloves throughout the box have these 'weak' areas and several create holes or tear as user is inserting hand into the glove. Currently have (2) boxes of this same lot affected. Currently no issues reported with the other sizes of halyard gloves.
 
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Brand NameHALYARD STERLING
Type of DeviceSPECIALTY -TESTED FOR USE WITH CHEMOTHERAPY - PATIENT EXAMINATION GLOVE
Manufacturer (Section D)
HALYARD HEALTH, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key6878539
MDR Text Key86756528
Report Number6878539
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue Number50706
Device Lot NumberSP7143ZZZ_08AX
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/07/2017
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer09/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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