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

Catalog Number 65872354

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

Patient Problem Numbness (2415)

Event Date 02/04/2014

Event Type  Injury  

Event Description

Reported to heraeus kulzer (b)(4) on (b)(6) 2014 by: (b)(6).On (b)(6); 5 days after the application the patient had numbness on her gum.Treatment tetracycline ointment and steroid ointment after the treatment on (b)(6), symptoms were improved soon.Remarks a substitute dentist applied gluma to the patient.Rinsing was not enough.This incident occurred in (b)(6).This is a serious injury (as defined in 21 cfr section 803.3) and requires intervention to prevent potential permanent harm to a body structure.This incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

Manufacturer Narrative

As allowed by exemption# (b)(4), heraeus kulzer llc (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the manufacturer).Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.(b)(4).Device has not been returned to the importer.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4062841
• MDR Text Key: 4899018
• Report Number: 9610902-2014-00044
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

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?: No
• Distributor Facility Aware Date: 08/21/2014
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/05/2014
• 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: 30 YR