MAUDE Adverse Event Report: EMERSON & CO., S. R. L. FREEGUARD RADIATION SURGICAL GLOVES; SURGEON'S GLOVES

Model Number RR1

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Product contains lead.Labeling indicates no lead.The info note indicates no lead.Labeling does not match the ifu for labeling claims of no lead.Https://www.Bar-ray.Com/products/gloves/1036/sterile-radiation-reducing-gloves.Fda safety report id# (b)(4).

• Brand Name: FREEGUARD RADIATION SURGICAL GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): EMERSON & CO., S. R. L.
• MDR Report Key: 8640728
• MDR Text Key: 146265256
• Report Number: MW5086898
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RR1
• Device Catalogue Number: BLACK LEAD FREE SURGICAL GLOVE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1