MAUDE Adverse Event Report: SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES W/ CHEMOTHERAPY LABELING CLAIMS - FOR USE W/ CHEMOTHERAPY DRUGS

Model Number SMTN253

Device Problems Product Quality Problem (1506); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

Starmed ultra nitrile exam glove was intact when removed from the box.However, the index finger ripped as soon as finger inserted.This product had been identified as having rips and unattached digits when removed from the box in the past but had never been saved.This is the first identification.

• 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 Key: 11958553
• MDR Text Key: 254908823
• Report Number: 11958553
• Device Sequence Number: 1
• Product Code: OPJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMTN253
• Device Catalogue Number: SMTN253
• Device Lot Number: L072304 2012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2021
• Event Location: Other
• Date Report to Manufacturer: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1