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

Lot Number L0794972103

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

Employee in wound care obtaining a glove out of a full box of gloves.Hole in thumb of glove when removed from box.

• 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; 13900 49th street north; clearwater FL 33762
• MDR Report Key: 12494744
• MDR Text Key: 272206110
• Report Number: 12494744
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: L0794972103
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1