MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for GLUMA DESENSITZING POWERGEL 66043451 manufactured by Kulzer, Gmbh.
[136234729]
Kulzer has notified the treating dds and educated them on the proper isolation techniques that are recommended and stated within the dfu. We will continue to keep in touch with the patient for any updates regarding extended symptoms as she continues to experience an altered state of tastes, after contacting all parties involved, it is apparent that this is due to user error as there was not isolation used and the dfu was not followed. 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 still experiencing an altered state of taste and has sought treatment with a secondary provider. The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution. (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
[136234730]
Patient went to treating dds and had gluma applied to their entire dentition. Material was applied by the hygienist. No isolation was used, material was not rinsed and the patient was sent home and instructed to not eat or drink anything for 30 minutes. Patient experienced burning and altered tastes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2019-00001 |
| MDR Report Key | 8339832 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2019-01-16 |
| Date Added to Maude | 2019-02-14 |
| 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 | 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-STRA[B 8/13 |
| Manufacturer City | WEHRHEIM, D-61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-61273 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLUMA DESENSITZING POWERGEL |
| Generic Name | DESENSITIZER |
| Product Code | LBH |
| Date Received | 2019-02-14 |
| Catalog Number | 66043451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2019-02-14 |