MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-10 for GLUMA 66043451 manufactured by Kulzer Gmbh.
[141586824]
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).
Patient Sequence No: 1, Text Type: N, H10
[141586825]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2019-00004 |
| MDR Report Key | 8501126 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-05 |
| Date Facility Aware | 2019-03-08 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AMBER BROWN |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5472995411 |
| Manufacturer G1 | KULZER GMBH |
| Manufacturer Street | PHILIPP-REIS-STRABE 8/13 |
| Manufacturer City | WEHRHEIM, D-61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-61273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUMA |
| Generic Name | DESENSITIZER |
| Product Code | KLE |
| Date Received | 2019-04-10 |
| Catalog Number | 66043451 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-10 |