MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA SURGICAL #5 PACK; SCALER, ULTRASONIC

Catalog Number PUSURG5

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

It was reported that proultra surgical #5 broke.As of this report it is unknown of any injury.

Manufacturer Narrative

Evaluation of the returned device found it was broken as indicated in the complaint.A dhr review was conducted with no discrepancies noted.

• Brand Name: PROULTRA SURGICAL #5 PACK
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 12977268
• MDR Text Key: 283672578
• Report Number: 2320721-2021-00110
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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 Catalogue Number: PUSURG5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/24/2021
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1