MAUDE Adverse Event Report: EMERSON & CO., S. R. L. FREEGUARD RADIATION ATTENUATING GLOVES; RADIOGRAPHIC PROTECTIVE GLOVE

Model Number MODEL 2, SIZE 8

Device Problems Material Puncture/Hole (1504); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2019

Event Type  malfunction  

Event Description

Freeguard radiation attenuating surgical gloves had large visible holes upon opening of sterile packaging.Fda safety report id# (b)(4).

• Brand Name: FREEGUARD RADIATION ATTENUATING GLOVES
• Type of Device: RADIOGRAPHIC PROTECTIVE GLOVE
• Manufacturer (Section D): EMERSON & CO., S. R. L. ; plaza della vittoria 10; genova 16121 ; IT 16121
• MDR Report Key: 9472987
• MDR Text Key: 171577395
• Report Number: MW5091677
• Device Sequence Number: 1
• Product Code: IWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: MODEL 2, SIZE 8
• Device Lot Number: 121216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1