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

Catalog Number 65872354

Device Problems Labelling, Instructions for Use or Training Problem (1318); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ulceration (2116)

Event Date 03/02/2015

Event Type  Injury  

Event Description

By way of (b)(6), email received from (b)(6), quality event form.Report from (b)(6) dental practice.Describes alleges harm event from (b)(6) 2015.(b)(6) female patient ((b)(6)) is having irritation/blistering and more toward back cheek and tonsil area.Product in question, gluma desensitizer liquid, was applied with a microbrush to dry area for crown prep.The patient had treatment 2/26 and came in 3/2 for follow up and advised reaction, tooth #30 (4th crown she's had w/doctor) patient was very angry.(b)(6) 2015 (b)(6) spoke with (b)(6) who will have (b)(6) call back.(b)(6) 2015 (b)(6) spoke with (b)(6) , who will have (b)(6) call back.(b)(6) 2015 (b)(6) spoke with (b)(6) at the office who stated that this patient showed her a copy of a recall letter for this product however, when (b)(6) checked it was not for this product or lot number.(b)(6) is not aware of how the patient got the letter.(b)(6) also mentioned as a result of the blistering that the patient received after this product was used on her she was sent to the er.As per (b)(6) , the office prescribed the patient antibiotics to take to help treat the blistering.This is a serious injury (as defined in 21 cfr section 803.3) as the patient reported having an adverse reaction and required intervention to prevent potential permanent harm to a body structure.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.This incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

Manufacturer Narrative

(b)(4).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 inadequate isolation, which is did not prevent product from contacting soft tissue.There was no known device problem, only failure to follow instructions.Has not been returned by dental practice.

• 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: 4648884
• MDR Text Key: 19350055
• Report Number: 9610902-2015-00008
• 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,Health Professional,Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2015

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 Expiration Date: 08/01/2017
• Device Catalogue Number: 65872354
• Device Lot Number: 010215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/09/2015
• Device Age: 7 MO
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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): Other; Required Intervention
• Patient Age: 35 YR