MAUDE Adverse Event Report: KULZER GMBH GLUMA; DESENSITIZER

Catalog Number 66043451

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

Patient Problems Pain (1994); Burning Sensation (2146); Ulcer (2274)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

User did not follow the manufacturer's instruction which state, ".Can cause local chemical burns.Protect mucus membranes from contact with the product by using a rubber dam.Apply the smallest possible amount of gluma desensitizing powergel required for one treatment." this was a severe injury, as the patient did not heal within the normal healing time of 2-10 days.Even though it occurred for a short amount of time, this injury affected the patient's daily life as she was on a liquid diet and had to apply multiple topical applications for palliative care.She also sought a second opinion for her injuries.(b)(4) has been in contact with the patient and has confirmed that as of 3/26/2019, the patient has stated that they have completely healed and have no residual symptoms.(b)(4).

Event Description

On 3/11/19 per patient: patient was seen in the office on (b)(6) and the hygienist applied gluma powergel to upper and lower posterior areas.She has sensitivity so the hygienist said they had a new product to office.The hygienist applied to her posterior teeth on the bottom and left it in for a minute and a half.When the patient was asked if the hygienist used a rubber dam, she stated the only thing the hygienist did was pull her cheek away from her teeth when she applied it.She then closed her mouth and then told the hygienist that her mouth was burning.She stated the tube the clinician used was green (which is our gluma powergel).Once the patient went home she noticed her tissue was sloughing off and it way greyish in color.She had sores on her gums, lips and bottom of the mouth.She went back to the dds on (b)(6) 2019.Dds said it was a new product and is a lot stronger.The patient is not able to eat, she is on a liquid diet.There is no longer any sloughing but the sores are still painful.The dds recommended that she rinse with warm salt water up to 5x a day, apply periosciences 3 x's a day and apply vitamin e 2x's a day.I told the patient i will follow up with the office and reviewed the directions for use with her, re-iterating the fact that we recommend in our directions for use to utilize a rubber dam to isolate the soft tissues as the material is known to be caustic to soft tissues.The patient agreed to let me follow up with her in a week to check on her healing.She stated she has been a patient of the dental office for 20 years, but after this incident, she is seeking treatment with another dds.On 3/14/19 per the dds: dr.Called and discussed the patient's treatment.Dr.Confirmed the patient was seen on (b)(6) 2019, and the hygienist applied gluma powergel.The office has been using regular gluma and just recently began using the powergel.Patient came into the office on friday.She had been taking 400mg of ibuprofen and the dds recommended something stronger but the patient declined.She also recommended no citrus, spicy foods or carbonated beverages.Dr.Stated the patient was using a chlorhexidine rinse at home which the she advised the patient to cease use.She also recommended the patient use perioscience gel, salt water rinses and vitamin e.The patient was using (b)(6) to remove the sloughing tissue and the dds advised her to stop as this could cause more irritation.Dr.Stated that the left vestibule is worse than the right and there is no visible tissue effects on the upper vestibular areas.The dr.Stated that she had spoken with the hygienist who applied the gluma last tuesday and the hygienist stated that the patient came in for a routine cleaning and suffers from recession and hypersensitivity.Hygienist applied mi paste prior to cleaning.At the end of the cleaning, the hygienist gave the option for desensitizing treatment.The hygienist told the dr.The material was applied using a mirror and finger for retraction.The patient claimed that she felt a burning sensation and the material was rinsed.After treatment, the patient had an itero scan and there was nothing clinically notable on the scan.Thursday (more than 48 hours after) the patient contacted the offices stating she had sores and tissue was still burning.

• Brand Name: GLUMA
• Type of Device: DESENSITIZER
• Manufacturer (Section D): KULZER GMBH; philipp-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): KULZER GMBH; philipp-reis-strabe 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: 8501126
• MDR Text Key: 141586824
• Report Number: 9610902-2019-00004
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66043451
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2019
• Event Location: Other
• Date Manufacturer Received: 03/08/2019
• 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): Other