MAUDE Adverse Event Report: HERAEUS KULZER GMBH GLUMA DESENSITIZER

Catalog Number 65872354

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

Patient Problems Swelling (2091); Numbness (2415)

Event Date 11/15/2016

Event Type  Injury  

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 21cfr 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.

Event Description

Patient was seen by her dds in (b)(6), on tuesday (b)(6) around 2 p.M.The treating dds applied gluma to her back molars on the lower left side.She had irritation at first.Later her lower and upper lip began to swell.Her cheek feels a little swollen and she is experiencing numbness down her neck.She stated that she seems to making extra saliva and her left eye is watery.Her symptoms are worse in the morning.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: DESENSITIZER
• Manufacturer (Section D): HERAEUS KULZER GMBH; philip-reis-strabe 8/13; wehrheim, gm D-612 73; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philip-reis-strabe 8/13; wehrheim, gm D-612 73; GM D-61273
• Manufacturer Contact: amber brown ; 4315 lafayette blvd.; south bend, IN 46614 ; 5742995411
• MDR Report Key: 6176994
• MDR Text Key: 62448925
• Report Number: 9610902-2016-00020
• 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: Other
• Type of Report: Initial
• Report Date: 11/18/2016

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: No Information
• Device Expiration Date: 08/24/2019
• Device Catalogue Number: 65872354
• Device Lot Number: 010505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2016
• Device Age: 3 MO
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2016
• 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