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

Catalog Number 65872354

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Burning Sensation (2146)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This 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.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.Directions for use indicate rubber dam use is required.The office used only cotton rolls for isolation, which is inadequate.Product not returned.

Event Description

This occurred in (b)(6).Call from patient - (b)(6) 2015: no return shipment expected.(b)(6).Patient was treated with gluma desensitizer on (b)(6) by dentist on tooth 46 without rubber dam.Both treatments were followed by severe necroses.The second time the patient saw during the weekend an emergency service.There, she received dentinox and kamistad gel - both products contain the same: chamomile extract and lidocaine hydrochloride - to reduce the severe burning sensation.Additionally she was treated there with a mixture out of cortisone and antibiotics.The dentist supposed an allergic reaction: she was neither aware that she should have applied rubber dam or immediately rinse the mucosa if gd gets in contact with.She solely used cotton rolls for protection.The dentist handed the msds to the patient and asked her to see an allergist for testing.The patient contacted heraeus kulzer after the weekend to seek advice before contacting an allergist.The patient additionally reported a nerve disturbance in her right hand, her cheek was swollen as well as her neck lymph nodes.

• 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: 5192385
• MDR Text Key: 30122091
• Report Number: 9610902-2015-00016
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/18/2015

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: 10/18/2015
• Initial Date Manufacturer Received: 10/18/2015
• Initial Date FDA Received: 10/30/2015
• 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; Required Intervention