MAUDE Adverse Event Report: HERAEUS KULZER, LLC DRI-CLAVE VK1; LEANER, ULTRASONIC, MEDICAL INSTRUMENT

Catalog Number 50036202

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 02/11/2015

Event Type  Injury  

Event Description

Call from staff at (b)(6); male dental assistant splashed vk-1 in eye as he placed a contaminated kit of dental tools into solution.This solution had been used for periodontal and oral surgery instruments.Staff inquired as to whether the product had disinfecting properties.I explained that the product was not a disinfectant, that it contained potassium hydroxide and sodium nitrate.The da was not experiencing any pain or burning, the eyes had been washed and he was going to seek medical care.I asked for product return and lot number, staff refused, saying it was the da's error, not the fault of product.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.Eye contact is addressed in the directions for use.The directions state,"concentrated detergent mixture contains potassium hydroxide 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." no failure of the medical device was detected.Eye irritation is a known inherent risks of using this medical device, and user error in failing to use adequate eye protection contributed to this event.Device was not returned to manufacturer.

• Brand Name: DRI-CLAVE VK1
• Type of Device: LEANER, 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: 4520188
• MDR Text Key: 5405166
• Report Number: 1925223-2015-00008
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Catalogue Number: 50036202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2015
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention