MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC HU-FRIEDY; ULTRA SONIC SCALER

Model Number 100

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/17/2016

Event Type  malfunction  

Event Description

Patient was having scaling done when the tip of the scaler broke and the patient is believed to have swallowed it.

• Brand Name: HU-FRIEDY
• Type of Device: ULTRA SONIC SCALER
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; chicago IL 60618
• MDR Report Key: 6193178
• MDR Text Key: 63085993
• Report Number: MW5066817
• Device Sequence Number: 1
• Product Code: EMN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 12/19/2016

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: Health Professional
• Device Model Number: 100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR