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

Lot Number 1703055605

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 12/26/2017

Event Type  malfunction  

Event Description

Hole in right glove.

• Brand Name: ENCORE
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): ANSELL HEALTHCARE LLC; 111 wood ave s. ste 210; iselin NJ 08830
• MDR Report Key: 7320694
• MDR Text Key: 101742707
• Report Number: 7320694
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/28/2020
• Device Lot Number: 1703055605
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2018
• Type of Device Usage: N
• Patient Sequence Number: 1