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U.S. Department of Health and Human Services

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

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KULZER, LLC GLUMA DESENSITIZER; AGENT, TOOTH BONDING, RESIN Back to Search Results
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.
 
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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 Key6911985
MDR Text Key88125037
Report Number9610902-2017-00014
Device Sequence Number1
Product Code KLE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962812
Number of Events Reported1
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 Number65872354
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/18/2017
Initial Date Manufacturer Received 09/18/2017
Initial Date FDA Received10/03/2017
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 Number1
Patient Outcome(s) Other;
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