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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEMPERMED USA INC STARMED ULTRA NITRILE M; SURGEON'S GLOVES
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SEMPERMED USA INC STARMED ULTRA NITRILE M; SURGEON'S GLOVES Back to Search Results
Catalog Number SMTN253
Device Problems Break (1069); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2019
Event Type  malfunction  
Event Description
Multiple gloves have been found to fall apart while attempting to put them on or have holes in the fingers and palms after removing from the box.This is an employee safety hazard for exposure to blood and body fluids.This is a recurring problem with this product at our facility.This facility has notified the manufacturer and has returned product.Manufacturer response for healthcare gloves, starmed ultra nitrile m (per site reporter).Manufacturer notified and product returned.
 
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Brand Name
STARMED ULTRA NITRILE M
Type of Device
SURGEON'S GLOVES
Manufacturer (Section D)
SEMPERMED USA INC
13900 49th street north
clearwater FL 33762
MDR Report Key9353859
MDR Text Key167366951
Report Number9353859
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 10/28/2019,10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberSMTN253
Device Lot NumberL042707 1906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2019
Event Location Hospital
Date Report to Manufacturer11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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