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

Model Number SMTN254

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Employee in wound care obtaining a glove out of a box.The thumb of the glove was ripped when removed.Glove saved and not used for patient care.5th event, same nature.Manufacturer response for sempermed starmed ultra nitrile exam gloves, (brand not provided) (per site reporter) aware.

• Brand Name: STARMED ULTRA NITRILE EXAM GLOVE
• Type of Device: MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS - TEST FOR USE WITH CHEMO
• Manufacturer (Section D): SEMPERMED USA, INC.; 13900 49th street north; clearwater FL 33762
• MDR Report Key: 15461155
• MDR Text Key: 300307331
• Report Number: 15461155
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• 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: L012271 2203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1