MAUDE Adverse Event Report: HERAEUS KULZER, LLC TARTAR AND STAIN REMOVER; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT

Catalog Number 50036330

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Swelling (2091); Ulcer (2274)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Narrative for codes: corrosive properties are addressed in the directions for use.The directions state,"contains sulfamic acid.Causes skin or eye irritation.Harmful if swallowed.In case of contact, flush eyes or skin with plenty of water.If irritation persists, seek medical attention." no failure of the medical device was detected.Manufacturer's dfu for the flexible partial material recommends the use of their own gentle cleaners.

Event Description

By way of patient: allegation of harm and complaints of painful soft tissue after flexible partial was placed in highly acidic tartar and stain remover.

• Brand Name: TARTAR AND STAIN REMOVER
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer (Section G): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5408668
• MDR Text Key: 37424940
• Report Number: 1821514-2016-00004
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Expiration Date: 01/04/2017
• Device Catalogue Number: 50036330
• Device Lot Number: 15010014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2015
• 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