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 Pain (1994); Swelling (2091); Caustic/Chemical Burns (2549); Tissue Breakdown (2681)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Directions for use indicate rubber dam use is required.The dentist indicated he deliberately put the desensitizer on the patient's tissue.This is off-label use.Device not returned.

Event Description

Patient reported the rdh put gluma on her lower anteriors slightly to left of center.He used no isolation and gluma got on her tissue.

• 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: 6069008
• MDR Text Key: 58843018
• Report Number: 9610902-2016-00017
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2016

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: Dental Hygienist
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/20/2016
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR