MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-10 for GLUMA DESENSITIZER POWERGEL 66043451 manufactured by Heraeus Kulzer Gmbh.
[33194855]
(b)(4). This incident is reportable according to 21 cfr 803. The fda defines this as a serious injury (21 cfr sec. 803. 3) as the patient reported having an adverse reaction. Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined. Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Directions for use indicate rubber dam use is required. The office did not adequate isolation and did not rinse the patient. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[33194856]
This occurred in (b)(6). Dds applied gluma desensitizer powergel without using rubber dam or rinsing off. The patient experienced a burning sensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2015-00018 |
| MDR Report Key | 5286236 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-10 |
| Date of Report | 2015-11-29 |
| Date Facility Aware | 2015-11-29 |
| Date Mfgr Received | 2015-11-29 |
| Date Added to Maude | 2015-12-10 |
| 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 | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | PHILIPP-REIS-STRASSE 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 DESENSITIZER POWERGEL |
| Generic Name | VARNISH, CAVITY |
| Product Code | LBH |
| Date Received | 2015-12-10 |
| Catalog Number | 66043451 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-10 |