MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC AFTER FIVE; SCALER, ULTRASONIC

Model Number	UI30SDL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, and race: patient weight, ethnicity, and race unknown.Other relevant history: no relevant history.Implant date, explant date: the device is not implanted.Concomitant medical products and therapy dates: no known concomitant medical products and therapy dates.
Event or Problem Description
A dental hygienist was performing perio maintenance when an instrument tip broke in the patients mouth and was ingested.The patient was advised to go to the hospital where images were taken.The tip was found in the descending colon but, no signs of perforation.The surgical team decided not to operate and wait for the tip to pass.

• Brand Name: AFTER FIVE
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• MDR Report Key: 8605797
• Report Number: 1416605-2019-00009
• Device Sequence Number: 2935238
• Product Code: ELC
• UDI-Device Identifier: 10889950075644
• UDI-Public: (01)10889950075644(10)0123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UI30SDL
• Device Catalogue Number: UI30SDL
• Device Lot Number: 02/17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR