MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-28 for GLUMA DESENSITIZER 65872354 manufactured by Kulzer Gmbh.
[112698404]
As allowed by exemption# (b)(4), (b)(4) is submitting the report on behalf of kulzer (b)(4) (the manufacturer). This is a serious injury (as defined in 21 cfr section 803. 3) this incident is being reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[112698405]
Dr called and he has a patient in the chair that had gluma applied to a class 5 restoration at the cervical root surface 2 days ago. The application was for 3 minutes and then the material was rinsed off. It is unclear as to whether isolation was used. The patient has suffered a tissue burn and the tissue is black in color and they are in pain. Tissue burns are known side affect of gluma if the material contacts soft tissues. The dfu recommends the use of a rubber dam for isolation to protect the soft tissues. Dfu also states an application time of 30-60 seconds, using the smallest amount of material as possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2018-00004 |
| MDR Report Key | 7648409 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-28 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-05-30 |
| Date Facility Aware | 2018-06-01 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-06-28 |
| 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-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 |
| Generic Name | DESENSITIZER |
| Product Code | KLE |
| Date Received | 2018-06-28 |
| Catalog Number | 65872354 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-28 |