MAUDE Adverse Event Report: HERAEUS KULZER GMBH GLUMA DESENSITIZER; AGENT, TOOTH BONDING, RESIN

Catalog Number 65872354

Device Problems Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 09/15/2014

Event Type  Injury  

Event Description

Dds called.(b)(4) took some info then transferred call to (b)(4).While working on a female (b)(6) patient yesterday, he and his assistant flicked a microbrush with gluma desensitizer and a droplet got into the patient's eye.She was not wearing glasses nor safety goggles as stated in the precautions dfu.They flushed her eye for 2-3 minutes, it felt better, but today it is still sensitive.The patient has not seen an eye doctor.(b)(4) offered and emailed dfu and msds to dds email.(b)(4) also asked dds to contact us with any other information and asked permission to follow up with dds to enquire about patient's condition.(b)(4) called back to arrange pickup of gd and replacement.Dds could not locate lot number of product.This is a serious injury (as defined in 21 cfr section 803.3) and requires intervention to prevent potentially 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

(b)(4).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.Method/results/conclusion: method: label evaluation states protective eyewear is required.Results: dds failed to follow instructions for use.Conclusion: device has not been returned, and dds failed to follow instructions.Device not returned.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• 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: 4166688
• MDR Text Key: 16542354
• Report Number: 9610902-2014-00046
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962812
• 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: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2014
• Date Manufacturer Received: 09/16/2014
• 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): Other; Required Intervention
• Patient Age: 60 YR