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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANSELL SANDEL MEDICAL SOLUTIONS LLC ENCORE LATEX MICRO; SURGEON'S GLOVES

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ANSELL SANDEL MEDICAL SOLUTIONS LLC ENCORE LATEX MICRO; SURGEON'S GLOVES Back to Search Results
Model Number 5787005
Device Problems Unsealed Device Packaging (1444); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2017
Event Type  malfunction  
Event Description
The surgeon changing into sterile gloves intraoperatively, when the wrapper for the gloves was opened a hair was adhered to one of the gloves.The gloves were discarded and another set was obtained.
 
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Brand Name
ENCORE LATEX MICRO
Type of Device
SURGEON'S GLOVES
Manufacturer (Section D)
ANSELL SANDEL MEDICAL SOLUTIONS LLC
111 wood avenue s.
suite 210
iselin NJ 08830
MDR Report Key6328862
MDR Text Key67356254
Report Number6328862
Device Sequence Number1
Product Code KGO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2017
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 Date08/31/2019
Device Model Number5787005
Device Lot Number1609007905
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/24/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age62 YR
Patient Weight54
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