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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC MEDICHOICE POLYISOPRENE SURGICAL GLOVES (DISTRIBUTED BY OWENS AND MINOR); SURGEON'S GLOVES
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ANSELL HEALTHCARE PRODUCTS LLC MEDICHOICE POLYISOPRENE SURGICAL GLOVES (DISTRIBUTED BY OWENS AND MINOR); SURGEON'S GLOVES Back to Search Results
Catalog Number SGL95085
Device Problem Material Integrity Problem (2978)
Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)
Event Date 04/20/2021
Event Type  malfunction  
Event Description
Patient underwent cataract surgery and developed toxic anterior segment syndrome (tass) post procedure.Surgical technician and surgeon noticed a difference in texture of the surgical gloves used in this particular case.The difference in texture raised concerns of surgical gloves possibly containing a powdered substance.The gloves in question are medichoice polyisoprene surgical gloves ref #sgl95085 with a lot number 2010525704.All gloves with this specific lot number were pulled from the operating room and isolated.
 
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Brand Name
MEDICHOICE POLYISOPRENE SURGICAL GLOVES (DISTRIBUTED BY OWENS AND MINOR)
Type of Device
SURGEON'S GLOVES
Manufacturer (Section D)
ANSELL HEALTHCARE PRODUCTS LLC
2301 robb drive
reno NV 89523
MDR Report Key11789641
MDR Text Key249458730
Report Number11789641
Device Sequence Number1
Product Code KGO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSGL95085
Device Lot Number2010525704
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/03/2021
Event Location Hospital
Date Report to Manufacturer05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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