MAUDE Adverse Event Report: KULZER, GMBH GLUMA DESENSITIZER POWERGEL; DESENSITIZING AGENT

Catalog Number 66043451

Device Problem Use of Device Problem (1670)

Patient Problems Edema (1820); Caustic/Chemical Burns (2549)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although we have established that user error caused the injuries to the patients and the patient did not seek treatment from a secondary provider, and all tissues have healthed without permanent damage, kulzer, llc is reporting this out of an abundance of caution, due to the (b)(6) requesting that this be reported and at the request of our global safety officer.

Event Description

Incident occured in (b)(6).(b)(6) yo female.Hyposalivation, smoker.Patient medications include lamictal and somac.After treatment with gluma desensitizer powergel, the patient had gingival injuries, headache, skin reaction, burning feeling, swelling/edema.Treating dds applied the product to what appears to be multiple areas.The dds did not use isolation, nor did they rinse the material after application.The product was applied and the patient was allowed to leave the office with the material still on the teeth.Per the office on (b)(6) 2018, the patient did not seek secondary treatment and they had been seen back at the office for a follow up visit and the provider was able to confirm that the injury has completely healed without permanent damage.

• Brand Name: GLUMA DESENSITIZER POWERGEL
• Type of Device: DESENSITIZING AGENT
• Manufacturer (Section D): KULZER, GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): KULZER GMBH; philipp-reis-stra?e 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer Contact: amber brown ; 4315 s. lafayette blvd; south bend, IN 46614 ; 5472995411
• MDR Report Key: 8096346
• MDR Text Key: 128097483
• Report Number: 9610902-2018-00005
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 66043451
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR