MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL HENRY SCHEIN SUPER CONCENTRATED GENERAL PURPOSE; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT

Catalog Number 1721362FG

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Reaction (2414)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

While using a schein sc ultrasonic gp 16oz cleaner, a hygienist experienced an allergic reaction.The hygienist broke out in a rash and went to go see her doctor for treatment.The patient was prescribed antibiotics and the symptoms abated approximately one week later.

Manufacturer Narrative

During dhr review audit, it was noticed that a calculation error was made when calculating % btc.The reported result was 7.20%.The correct calculation produces 7.99%.The specification for the product is 6.13-7.49%.No other errors were found during the audit.

• Brand Name: HENRY SCHEIN SUPER CONCENTRATED GENERAL PURPOSE
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178457551
• MDR Report Key: 6487280
• MDR Text Key: 72622339
• Report Number: 2424472-2017-00034
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1721362FG
• Device Lot Number: 160915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention