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

Catalog Number 66001854

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Anaphylactoid (2218); Reaction (2414)

Event Date 01/25/2016

Event Type  Injury  

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).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.Code narrative: directions for use indicate rubber dam use is required.Device was not returned.

Event Description

Male patient called with report of emergency room care one hour after dental appointment.The patient stated no rubber dam was used.

• 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: 5408286
• MDR Text Key: 37423247
• Report Number: 9610902-2016-00004
• 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: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2016

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: Dentist
• Device Catalogue Number: 66001854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/28/2016
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention