MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. FITGUARD SELECT NITRILE EXAM GLOVES; POLYMER PATIENT EXAMINATION GLOVE

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 09/25/2016

Event Type  malfunction  

Event Description

While nurse was in an isolation room tending to a patient, she noticed a tear in the glove.

• Brand Name: FITGUARD SELECT NITRILE EXAM GLOVES
• Type of Device: POLYMER PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 6134967
• MDR Text Key: 61152599
• Report Number: 6134967
• Device Sequence Number: 1
• Product Code: LZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: FG2602
• 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: 11/02/2016
• Event Location: Other
• Date Report to Manufacturer: 11/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1