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

Catalog Number 65872354

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Swelling (2091); Caustic/Chemical Burns (2549); Tissue Breakdown (2681)

Event Date 11/18/2015

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 and required medical intervention to prevent further injury.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.Narrative: directions for use indicate rubber dam use is required.The office used only gauze for isolation, which is inadequate.Product not returned to manufacturer.

Event Description

(b)(6) female patient reporting adverse reaction to gluma desensitizer.Gluma desensitizer placed (b)(6) 2015 after grafting surgery of lower anterior had been done on (b)(6) 2015.Patient stated gauze was used inside lower lip, does not remember being rinsed.Was told not to eat or drink for 30 minutes.

• 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: 5471500
• MDR Text Key: 39416544
• Report Number: 9610902-2016-00007
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/25/2016

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: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2016
• 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
• Patient Age: 72 YR