MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-21 for GLUMA DESENSITIZER 65872354 manufactured by Kulzer Gmbh - Hq.
[188544930]
Kulzer statement on (b)(6) comment: we are very sorry for the injury you suffered. It is a chemical burn that may come about if the product comes in contact with unprotected soft tissues in the mouth. It could have been prevented with the use of a rubber dam to protect the soft tissue and using a minimal amount of desensitizing agent on the brush. These recommendations are stated in the dentist's instructions for use. The burn is self-healing and the soft tissue will regenerate normally within 5 to 10 days. For more information please do not hesitate to contact our safety management at gsm@kulzer-dental. Com the patient did not reply on kulzer statement until the date of this report.
Patient Sequence No: 1, Text Type: N, H10
[188544931]
Patient experienced burned lip, horrible dry mouth and burning sensation on tongue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2020-00001 |
| MDR Report Key | 9738879 |
| Report Source | OTHER |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. ALBERT ERDRICH |
| Manufacturer Street | LEIPZIGER STRASSE 2 |
| Manufacturer City | HANAU, HESSE 63450 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63450 |
| Manufacturer G1 | KULZER GMBH - KDEW |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM, HESSE 61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 61273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUMA DESENSITIZER |
| Generic Name | DESENSITIZER |
| Product Code | KLE |
| Date Received | 2020-02-21 |
| Catalog Number | 65872354 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH - HQ |
| Manufacturer Address | LEIPZIGER STRASSE 2 HANAU, HESSE 63450 GM 63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-21 |