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

Lot Number WSM11115187

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/01/2019

Event Type  malfunction  

Event Description

The medline sterile nitrile examination gloves were opened in sterile conditions.One of the gloves in the pack had debris inside the glove.

• Brand Name: MEDLINE PROCEDURE EXAM GLOVES
• Type of Device: POLYMER PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9213859
• MDR Text Key: 163167826
• Report Number: MW5090494
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: WSM11115187
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1