MAUDE Adverse Event Report: DENTSPLY LLC 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC

Catalog Number 82005

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Exposure to Body Fluids (1745); Laceration(s) (1946); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

This incident resulted in an injury or illness that is life-threatening, therefore this event does meet the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and a risk management review is planned.The results will be submitted as they become available.

Event Description

A dental assistant reported: "after i used the cavitron in my patient's mouth i placed it back in its holder.The point on the tip was facing me, my back was facing the tray.As i turned around to my right to look at the chart on the computer my elbow grazed the tip of the cavitron and it sliced my elbow.The patient in the chair was (b)(6).We proceeded to the urgent care and followed the protocol.Her blood test came up (b)(6) at the clinic and they insisted on prescribing two prescriptions to be taken every day for 30 days: (b)(6) tablets.I returned for blood work 2 weeks in a row.Last friday the doctor called and told me to stop (b)(6) as it was affecting my kidney function.When i went back to get retested on tuesday, my kidney levels were getting back to normal and it was recommended that i go back on (b)(6) and complete the regime.".

Manufacturer Narrative

The product was not returned for evaluation.However, this incident is not the result of a product malfunction.Risk management review was completed.New harm was added into the product fmea.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10S STRAIGHT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 8056715
• MDR Text Key: 126891645
• Report Number: 2424472-2018-00177
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82005
• Device Lot Number: 18130, 00006079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention