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

Model Number FG2602

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2016

Event Type  malfunction  

Event Description

While attempting to put the gloves on, the gloves ripped at the base of the glove.Concern with easy ripping of the gloves.

• 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: 6135376
• MDR Text Key: 61151472
• Report Number: 6135376
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FG2602
• Device Catalogue Number: FG2602
• Device Lot Number: EG608567553
• 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: 10/27/2016
• Event Location: Other
• Date Report to Manufacturer: 10/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1