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

Model Number 65872354

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

Patient Problem Burning Sensation (2146)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a serious injury (as defined in 21 cfr section 803.3) as the patient reported having an adverse reaction.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.This incident is being reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Directions for use indicate rubber dam use is required.The office did not maintain isolation.By immediately rinsing patient the dental assistant prevented further tissue injury.Device not returned to manufacturer.

Event Description

Dental assistant used gluma desensitizer on a female patient and did not maintain isolation.Patient complained of burning sensation.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5783634
• MDR Text Key: 49203588
• Report Number: 9610902-2016-00010
• 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: Dental Assistant
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Model Number: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/16/2016
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: 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