MAUDE Adverse Event Report: ANSELL SANDEL MEDICAL SOLUTIONS LLC ENCORE LATEX MICRO; SURGEON'S GLOVES

Model Number 5787005

Device Problems Unsealed Device Packaging (1444); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/18/2017

Event Type  malfunction  

Event Description

The surgeon changing into sterile gloves intraoperatively, when the wrapper for the gloves was opened a hair was adhered to one of the gloves.The gloves were discarded and another set was obtained.

• Brand Name: ENCORE LATEX MICRO
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): ANSELL SANDEL MEDICAL SOLUTIONS LLC; 111 wood avenue s.; suite 210; iselin NJ 08830
• MDR Report Key: 6328862
• MDR Text Key: 67356254
• Report Number: 6328862
• 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: Other
• Type of Report: Initial
• Report Date: 01/24/2017

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: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 5787005
• Device Lot Number: 1609007905
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 54