MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TRIUMPH; LATEX SURGEON'S GLOVES

Model Number MSG2275

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/22/2015

Event Type  malfunction  

Event Description

A physician opened a pair of 7 1/2 size sterile latex triump surgical gloves that appears to have brown marking on the outside lateral aspect of the right hand glove pinky or little finger.

• Brand Name: TRIUMPH
• Type of Device: LATEX SURGEON'S GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6653080
• MDR Text Key: 77941796
• Report Number: 6653080
• Device Sequence Number: 1
• Product Code: KGO
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/22/2015,06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/01/2018
• Device Model Number: MSG2275
• Device Catalogue Number: MSG2275
• 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: 10/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1