MAUDE Adverse Event Report: SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES WITH CHEMOTHERAPY

Model Number SMTN254

Device Problems Defective Device (2588); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2020

Event Type  malfunction  

Event Description

Starmed ultra nitrile l glove was ripped from wrist to finger opening of 4th and 5th finger.Defective glove and associated box of gloves available for return to manufacturer.Manufacturer response for healthcare gloves, starmed ultra nitrile l (per site reporter).Waiting on feedback from manufacturer if request defective product for investigation.

• 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 Key: 10167118
• MDR Text Key: 195549937
• Report Number: 10167118
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMTN254
• Device Catalogue Number: SMTN254
• Device Lot Number: 2020-01 L052000 2001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1