MAUDE Adverse Event Report: HERAEUS KULZER GMBH GLUMA ETCH 35 FLUID 15ML FL; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Catalog Number 66000129

Device Problem Device Issue (2379)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/27/2015

Event Type  Injury  

Event Description

(b)(6) called because he said he placed some gluma etch 35% fluid on a patients tooth and when he rinsed it off, a little got into his patient's eye.He asked what he should do.I read from the msds, "after eye contact rinse opened eye for several minutes under running water.Then consult a doctor." he said he did rinse it and she had on sunglasses and wore contacts.I asked if the patient was still in the chair and he said no.I asked if he would like a copy of the msds and he said no.I asked if the patient was going to seek medical attention and he said he didn't know.I asked if i could get some information on the incident to document this and he said that he needed to get off the phone and advise her to see her doctor.On (b)(6) 2015, i called the office back and spoke to eve.I explained who i was and that i was calling to see if the doctor had a moment to speak to me so i could get more information.She said he is busy with a patient right now.I asked if she could at least tell me the percentage and if it was fluid or gel.She said it was the fluid.I asked if she could read me the lot number.I asked if she had spoken to the patient since and if she sought medical attention.She said the patient has not returned any calls.I asked if we could follow up with her in about a week or if she could contact me if she hears from the patient.She said we could call or she will call if she hears anything and took my name and number down.I plugged the lot number into the system after hanging up with eve and realized it expired 9/30/2007.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

As allowed by exemption # (b)(4), (b)(4) (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the manufacturer).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.Evaluation summary: directions for use indicate avoid contact with the eyes.The office failed to exercise adequate precautions, and the product got in the patient's eye.Also the product expiration date is nearly 8 years past.Device not returned by dentist.

• Brand Name: GLUMA ETCH 35 FLUID 15ML FL
• Type of Device: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4755334
• MDR Text Key: 21330531
• Report Number: 9610902-2015-00009
• Device Sequence Number: 1
• Product Code: EBZ
• Combination Product (y/n): N
• PMA/PMN Number: K770113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 09/30/2007
• Device Catalogue Number: 66000129
• Device Lot Number: 010284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/27/2015
• Device Age: 11 YR
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2004
• 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; Required Intervention