Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES WITH CHEMOTHERAPY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES WITH CHEMOTHERAPY Back to Search Results
Model Number SMTN253
Device Problems Defective Device (2588); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2020
Event Type  malfunction  
Event Description
Radiology technician pulled a glove out of glove box.Glove was missing index and middle fingers.Defective glove not saved.This is a recurring problem.The manufacturer has been notified.Multiple affected product samples have been returned.The problem continues.Multiple lots within multiple catalog numbers are affected.Manufacturer response for healthcare glove, starmed ultra nitrile m (per site reporter).Quality event report submitted to manufacturer.
 
Event Description
Radiology technician pulled a glove out of glove box.Glove was missing index and middle fingers.Defective glove not saved.This is a recurring problem.The manufacturer has been notified.Multiple affected product samples have been returned.The problem continues.Multiple lots within multiple catalog numbers are affected.Manufacturer response for healthcare glove, starmed ultra nitrile m (per site reporter).Quality event report submitted to manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STARMED ULTRA NITRILE EXAM GLOVE
Type of Device
MEDICAL GLOVES WITH CHEMOTHERAPY
Manufacturer (Section D)
SEMPERMED USA, INC.
13900 49th street north
clearwater FL 33762
MDR Report Key10028344
MDR Text Key190003340
Report Number10028344
Device Sequence Number1
Product Code OPJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSMTN253
Device Catalogue NumberSMTN253
Device Lot NumberL048829 1911
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-