MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-21 for GLUMA DESENSITIZER POWERGEL 66043451 manufactured by Kulzer, Gmbh.
[128097483]
(b)(4). Although we have established that user error caused the injuries to the patients and the patient did not seek treatment from a secondary provider, and all tissues have healthed without permanent damage, kulzer, llc is reporting this out of an abundance of caution, due to the (b)(6) requesting that this be reported and at the request of our global safety officer.
Patient Sequence No: 1, Text Type: N, H10
[128097484]
Incident occured in (b)(6). (b)(6) yo female. Hyposalivation, smoker. Patient medications include lamictal and somac. After treatment with gluma desensitizer powergel, the patient had gingival injuries, headache, skin reaction, burning feeling, swelling/edema. Treating dds applied the product to what appears to be multiple areas. The dds did not use isolation, nor did they rinse the material after application. The product was applied and the patient was allowed to leave the office with the material still on the teeth. Per the office on (b)(6) 2018, the patient did not seek secondary treatment and they had been seen back at the office for a follow up visit and the provider was able to confirm that the injury has completely healed without permanent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2018-00005 |
| MDR Report Key | 8096346 |
| Report Source | FOREIGN |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-21 |
| 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 | 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?E 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 POWERGEL |
| Generic Name | DESENSITIZING AGENT |
| Product Code | KLE |
| Date Received | 2018-11-21 |
| Catalog Number | 66043451 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-21 |