MAUDE Adverse Event Report: HERAEUS KULZER, LLC DRI-CLAVE VK4; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT

Catalog Number 500360208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

Call from patient, who identified herself as (b)(6) call was from unknown number.Patient stated she had been given our information by her dds.Patient stated the last two times she had her teeth cleaned, upon putting her partial back into her mouth, she had nearly immediate intense pain on her palate.Patient stated she suffered for three weeks with sore palate symptoms and was supplied cream to help with the healing.Dds let her read the gallon container containing the product in question, which is dri-clave vk4, and supplied her with msds.Patient states she is allergic to peg (phenyl ethyl glycol)and wanted to know if that was contained in our product.I read the label to her as well, and noted the product needs to be neutralized with sodium bicarb and water.There is no indication that this step is being taken.Phoned the dental office to inform them of proper procedures, without disclosing patient information.Informed patient that i could not give her medical advice nor determine her potential reaction to our products, but i did recommend that she avoid tartar and stain remover in the future.She may follow through with additional allergy testing.This is a serious injury (as defined in 21 cfr section 803.3) and requires intervention to prevent potential permanent harm to a body structure.This incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

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.Tissue irritation is addressed in the directions for use.The cautionary label states,"corrosive liquid.Acidic detergent mixture contains sulfamic acid, alkyl dimethyl benzyl ammonium chloride and isopropyl alcohol.May cause 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.If swallowed, drink large quantities of water.Call a physician immediately." also, under dfu: "dentures, bridges, orthodontics appliances and other acrylic items should be neutralized in a solution of 1 teaspoon bicarbonate of soda diluted in a cup of water.No failure of the medical device was detected.Tissue irritation is a known inherent risks of using this medical device, and user error in failing to adequately neutralize product contributed to this event.Product not returned by dental practice.

• Brand Name: DRI-CLAVE VK4
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 251
• Manufacturer (Section G): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 251
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4648177
• MDR Text Key: 5757039
• Report Number: 1925223-2015-00014
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Catalogue Number: 500360208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR