HU-FRIEDY SM 13/14S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-17 for HU-FRIEDY SM 13/14S manufactured by Hu-friedy Mfg. Co.,inc..

Event Text Entries

[15032711] During dental procedure 1 to 1. 5 cm of tip of posterior universal hand scaler broke off in pt's mouth. Attempts to recover by suction were unsuccessful. Chest x-ray revealed aspiration into left lung. Object was surgically removed. Pt returned to home the same day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 197769
• MDR Report Key: 197769
• Date Received: 1998-11-17
• Date of Report: 1998-10-22
• Date of Event: 1998-10-13
• Date Facility Aware: 1998-10-13
• Report Date: 1998-10-22
• Date Reported to Mfgr: 1998-10-22
• Date Added to Maude: 1998-11-20
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HU-FRIEDY
• Generic Name: MCCALL DOUBLE-ENDED SCALER
• Product Code: EMN
• Date Received: 1998-11-17
• Model Number: SM 13/14S
• Catalog Number: SM 13/14S
• Lot Number: NA
• ID Number: MARKING OF "SQUARE" ON HANDLE
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 8 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 192142
• Manufacturer: HU-FRIEDY MFG. CO.,INC.
• Manufacturer Address: 3232 NORTH ROCKWELL ST. CHICAGO IL 606185935 US
• Baseline Brand Name: HU-FRIEDY
• Baseline Generic Name: MCCALL DOUBLE-ENDED SCALER
• Baseline Model No: SM 13/14S
• Baseline Catalog No: SM 13/14S
• Baseline ID: MARKING OF "SQU

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-11-17