MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-21 for GLUME DESENSITIZER 65872354 manufactured by Kulzer Gmbh.
[145643371]
This material is known to be caustic to soft tissue. Our dfu states "to protect mucous membranes by using a rubber dam. Make sure that gluma desensitizer only comes into contact with the area to be treated. Make sure that only the smallest possible amount required is applied and that it only comes into contact with the area to be treated. ... It is a local irritant and has toxic effects. Appropriate precautions should always be taken before using gluma desensitizer". Per the patient, there was no rubber dam used prior to the initial application of this product. Follow up calls to patient determined that the healing process is still ongoing and she is under treatment with pcp. Kulzer (b)(4) has evaluated based on the given information of the patient that the device has caused the injuries due to a wrong application procedure and a lack of protection measures. Kulzer (b)(4) reports this incident out of caution to be compliant with 21 cfr 803 and out of abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[145643372]
Patient was seen in office for anterior veneers. After the prep, gluma was placed by the dental assistant prior to having the temporary crowns placed. Pt immediately began feeling a burning sensation and notified the dental assistant. There was no rubber dam or barrier protection placed prior to the gluma desensitizer. Patient was told to spit out the product and was given water to rinse out with. The dr then returned to the room and "painted on" the gluma and seated the temporaries. Patient was seen at the er the day after with complaints of a burning sensation and irritation on her lips and gums. Patient was also seen by her primary medical dr for the same concerns. Patient was prescribed ibuprofen, prednisone and some mouthwash ((b)(6) mouthwash).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2019-00005 |
| MDR Report Key | 8627914 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-21 |
| Date of Report | 2019-08-01 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-05-03 |
| Date Added to Maude | 2019-05-21 |
| 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 | MR. ALBERT ERDRICH |
| Manufacturer Street | LEIPZIGER STRASSE 2 |
| Manufacturer City | HANAU, 63450 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63450 |
| Manufacturer G1 | KULZER GMBH - WEHRHEIM |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM, 61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 61273 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUME DESENSITIZER |
| Generic Name | DESENSITIZING AGENT |
| Product Code | KLE |
| Date Received | 2019-05-21 |
| Catalog Number | 65872354 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | LEIPZIGER STRASSE 2 HANAU, 63450 GM 63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-21 |