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

Model Number SMTN253

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2020

Event Type  malfunction  

Event Description

Starmed ultra nitrile glove noted to be damaged when removed from the box.One glove was stuck inside another glove.Gloved appeared to be matted or melted together.Glove available for return to manufacturer.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 gloves, starmed ultra nitrile s (per site reporter).Quality event report submitted to manufacturer.

• 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: 10028318
• MDR Text Key: 190002941
• Report Number: 10028318
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMTN253
• Device Catalogue Number: SMTN253
• Device Lot Number: L048828 1911
• 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: 04/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1