MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-19 for GLUMA DESENSITIZER POWERGEL 66043451 manufactured by Heraeus Kulzer Gmbh.
[49861137]
(b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative: according the directions for use gluma powergel the user should protect mucous membranes from contact with the product using a rubber dam.
Patient Sequence No: 1, Text Type: N, H10
[49861138]
Dr. Applied gluma power gel to the buccals of upper left premolars and molars after restorative work. Dental assistant stated that there was no isolation used during the application of the gluma product. Patient returned to the office today complaining of pain and extreme sensitivity of the teeth and burning of the lip. Treating dds seen patient that day and diagnosed him with tissue irritation. Dds applied petroleum jelly topically and gave a prescription for percocet. Dds recommended that patient reapply petroleum jelly at home. Patient was scheduled for a prophylaxis appointment and to follow up with dds. Patient did not keep the scheduled appointments and the office staff has not been able to contact the patient, therefore, no further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2016-00012 |
| MDR Report Key | 5803973 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-06-22 |
| Date Facility Aware | 2016-06-23 |
| Date Mfgr Received | 2016-06-23 |
| Date Added to Maude | 2016-07-19 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AMBER BROWN |
| Manufacturer Street | 4315 LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995411 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | PHILIPP-REIS-STRABE 8/13 |
| Manufacturer City | WEHRHEIM, GM 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 DESENSITIZER POWERGEL |
| Generic Name | VARNISH, CAVITY |
| Product Code | LBH |
| Date Received | 2016-07-19 |
| Catalog Number | 66043451 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIP-REIS-STRABE 8/13 WEHRHEIM, GM D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-19 |