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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS
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SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS Back to Search Results
Lot Number L074702
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/28/2021
Event Type  malfunction  
Event Description
When the starmed ultra nitrile exam gloves were removed from box, it was evident that they were ¿ripped¿ in box- prior to removal.Two separate events.(1) a glove was removed from the box and was ripped from the wrist all the way through the thumb.Mfg date/lot# 2021-01 l074702 2101 size large.The box was retained.(2) box of medium starmed nitrile gloves, the first glove was found to be badly ripped and unusable.This issue has been a recurrent problem recently.Our center's glove spend has drastically increased this year and staff report it is due to high numbers of unusable gloves.Mfg item number smtn253.Date and lot # 2021-02 l076327 2102(not saved).Sempermed usa, inc.Will look into the recurrent issues.
 
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Brand Name
STARMED ULTRA NITRILE EXAM GLOVE
Type of Device
MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS
Manufacturer (Section D)
SEMPERMED USA, INC.
13900 49th street north
clearwater FL 33762
MDR Report Key12335851
MDR Text Key267071190
Report Number12335851
Device Sequence Number1
Product Code OPJ
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 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberL074702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/05/2021
Event Location Hospital
Date Report to Manufacturer08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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