MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC ENCORE LATEX ACCLAIM; SURGEON'S GLOVE

Model Number LEFT GLOVE, SIZE 6

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2019

Event Type  malfunction  

Event Description

While inspecting the left glove prior to donning, two holes were found in the glove.The holes have the appearance of a punch hole and is in two layers of the folded glove.This occurred with two separate pairs of gloves from the same lot.Neither reached a patient.

• Brand Name: ENCORE LATEX ACCLAIM
• Type of Device: SURGEON'S GLOVE
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC
• MDR Report Key: 8366827
• MDR Text Key: 137299792
• Report Number: MW5084328
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: LEFT GLOVE, SIZE 6
• Device Catalogue Number: CE00086
• Device Lot Number: 1712571504
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1