MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-18 for GLUMA DESENSITIZER 66003764 manufactured by Kulzer Gmbh.
[130674598]
The directions for use state, "protect mucous membranes by using a rubber dam". Even though this is clearly the result of user error, the treating dds had the patient stop his medication after consulting with the patient's physician for a week and had him under observation following antibiotics to prevent super infection. (b)(4). This single mdr will satisfy the reporting obligation for both firms under 21 cfr parts 803. 40, 803. 42, 803. 50(a)(1), 803. 50(a)(2) and 803. 52.
Patient Sequence No: 1, Text Type: N, H10
[130674599]
Dentist had a case of patient presenting with dentine sensitivity and "recommend" the use of gluma desensitizer. But while handling the gluma in the oral cavity the patient spread the gluma placed "through" his tongue all over his cheek and palate. He was drinking lukewarm water for the past day and had slight discomfort earlier. He reported after 24 hours with widespread firm swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2018-00006 |
| MDR Report Key | 8174683 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-18 |
| Date Facility Aware | 2018-11-19 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-18 |
| 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, LLC |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| 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 | 2018-12-18 |
| Catalog Number | 66003764 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-18 |