MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-07-02 for GLUMA DESENSITIZER 65872354 manufactured by Kulzer Gmbh.
| Report Number | 9610902-2019-00008 |
| MDR Report Key | 8752900 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-07-02 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-06-20 |
| Date Added to Maude | 2019-07-02 |
| 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 | MR ALBERT ERDRICH |
| Manufacturer Street | LEIPZIGER STRASSE 2 |
| Manufacturer City | HANAU, HESSE 63450 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63450 |
| Manufacturer G1 | KULZER GMBH - WEHRHEIM |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM, HESSE 61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 61273 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUMA DESENSITIZER |
| Generic Name | DESENSITIZING AGENT |
| Product Code | KLE |
| Date Received | 2019-07-02 |
| Catalog Number | 65872354 |
| Lot Number | 010210 |
| Device Expiration Date | 2016-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | LEIPZIGER STRASSE 2 HANAU, HESSE 63450 GM 63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-02 |