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

Model Number UI30SDL

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2019

Event Type  Injury  

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 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
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60618 ; 7738685676
• MDR Report Key: 8605797
• MDR Text Key: 144888935
• Report Number: 1416605-2019-00009
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075644
• UDI-Public: (01)10889950075644(10)0123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR