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

Model Number SMTN253

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

Glove removed from box.Glove appeared to be glued together.Manufacturer response for medical gloves, star med ultra nitrile glove (per site reporter).Reported to semper med customer service.Event report and pictures reported to manufacturer.

• Brand Name: STARMED ULTRA NITRILE EXAM GLOVE
• Type of Device: MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS - TEST FOR USE WITH CHEMOTHERAP
• Manufacturer (Section D): SEMPERMED USA, INC.; 13900 49th street north; clearwated FL 33762
• MDR Report Key: 18873660
• MDR Text Key: 337322041
• Report Number: 18873660
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: L028264
• 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: 02/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1