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

Catalog Number 65872354

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

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.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.The incident will be reported to maintain compliance with 21 cfr803 and out of an abundance of caution.Directions for use indicate rubber dam use is required, to use the smallest amount possible, and not to use if patient is allergic to any of the ingredients.The hygienist failed to maintain isolation of the patient's soft tissue and also applied gluma desensitizer too heavily.

Event Description

Patient reports hygienist used no isolation and treated multiple sites with five coats of gluma desensitizer.Patient reported she went to emergency room feeling ill and with burns on her gum tissue.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): KULZER, LLC; philipp-reis-strasse 8/13; wehrheim, hessen 61273 ; GM 61273
• Manufacturer (Section G): KULZER, LLC; 4315 south lafayette blvd.; south bend 46614
• Manufacturer Contact: rita rogers ; 4315 lafayette blvd; south bend, IN 46614
• MDR Report Key: 6911985
• MDR Text Key: 88125037
• Report Number: 9610902-2017-00014
• 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: Other
• Type of Report: Initial
• Report Date: 09/18/2017

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 Hygienist
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2017
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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