MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for GLUMA DESENSITIZER 65872354 manufactured by Kulzer Gmbh.
[179808624]
(b)(6) user comment on video "explaining gluma desensitizer (en). " (b)(6) i just had some applied a few hours ago. Not only did it not help the pain, it burned my lip and gave me horrible dry mouth. The dentist claims they've never seen these side effects before. I felt a drop fall on my tongue and i felt a burning sensation. They wiped it off but i've been having problems since. Beware! (b)(4) statement on (b)(6) comment: we are very sorry for the injury you suffered. It is a chemical burn that may come about if the product comes in contact with unprotected soft tissues in the mouth. It could have been prevented with the use of a rubber dam to protect the soft tissue and using a minimal amount of desensitizing agent on the brush. These recommendations are stated in the dentist's instructions for use. The burn is self-healing and the soft tissue will regenerate normally within 5 to 10 days. For more information please do not hesitate to contact our safety management at (b)(4) screen shot (b)(6). This incident is reportable according to 21 cfr 803. The fda defines this as a serious injury(21 cfr sec. 803. 3) this incident came to our attention via (b)(6) comment. A patient commented that after gluma was applied it burned his lip and gave him dry mouth, he also felt a drop contact his tongue and felt a burning sensation. The incident will be reported to maintain compliance with 21 cfr 803. Due to the fact that (b)(4) does not have the patient's contact information, the patient's injuries and healing status cannot be verified. It also cannot be determined if there was medical intervention. (b)(4) is reporting out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[179808625]
Patient experienced burned lip, horrible dry mouth and burning sensation on tongue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2020-00002 |
| MDR Report Key | 9700768 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-23 |
| Date Facility Aware | 2020-01-23 |
| Report Date | 2020-02-12 |
| Date Reported to Mfgr | 2020-02-12 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUMA DESENSITIZER |
| Generic Name | DESENSITIZER, PRODUCT CODE: LBH |
| Product Code | LBH |
| Date Received | 2020-02-12 |
| Catalog Number | 65872354 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-12 |