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

Model Number RIGHT GLOVE SIZE 8

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/04/2019

Event Type  malfunction  

Event Description

While donning the right glove, a hole was found in the glove; it appears to be a punch hole.It did not reach a patient.

• Brand Name: ENCORE LATEX ACCLAIM
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC
• MDR Report Key: 8366828
• MDR Text Key: 137303835
• Report Number: MW5084329
• 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

1 Device was Involved in the Event

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: 12/01/2020
• Device Model Number: RIGHT GLOVE SIZE 8
• Device Catalogue Number: CE00086
• Device Lot Number: 18011406404
• 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