MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC PATTERSON® THIN ULTRASONIC INSERT - # 100, 30 KHZ; SCALER, ULTRASONIC

Model Number	121-6993
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User facility disposed of device.With the device not being returned, root cause analysis of the issue is limited.The return and complaint rates for 121-6993 are low and this is the only complaint for 121-6993.Review of dhr shows no indication of defects were noted which would have contributed to the complaint of the device.The package insert, n4324, for 121-6993 states "prior to each use: inspect, clean and sterilize.Ultrasonic inserts that have compromising conditions such as being bent, altered, or worn should not be used.".
Event or Problem Description
User facility reported to patterson that the device is tearing up people's gums.

• Brand Name: PATTERSON® THIN ULTRASONIC INSERT - # 100, 30 KHZ
• Common Device Name: 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: stephanie wasielewski ; 1666 e. touhy ave.; des plaines, IL 60018 ; 8472574500
• MDR Report Key: 19949118
• Report Number: 1416605-2024-00007
• Device Sequence Number: 15693787
• Product Code: ELC
• UDI-Device Identifier: D6620712169930
• UDI-Public: D6620712169930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: 121-6993
• Device Catalogue Number: 121-6993
• Device Lot Number: 0423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown