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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SVS LLC PREMIERPRO PLUS; POWDERED LATEX SURGEON'S GLOVES

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SVS LLC PREMIERPRO PLUS; POWDERED LATEX SURGEON'S GLOVES Back to Search Results
Lot Number MTH11-17
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  malfunction  
Event Description
When nurse was putting on gloves, she felt debris in the tip of the glove on the middle finger, removed the glove and took the box of gloves out of service.Unable to determine the source of the debris.
 
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Brand Name
PREMIERPRO PLUS
Type of Device
POWDERED LATEX SURGEON'S GLOVES
Manufacturer (Section D)
SVS LLC
14120 ballantyne corporate pl ste 425
charlotte NC 28277
MDR Report Key9585991
MDR Text Key174880214
Report Number9585991
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 Other Health Care Professional
Type of Report Initial
Report Date 12/26/2019
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 Health Professional
Device Lot NumberMTH11-17
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/26/2019
Event Location Hospital
Date Report to Manufacturer01/14/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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