MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-28 for GLUMA DESENSITIZER 65872354 manufactured by Kulzer, Llc.
[103653873]
Follow up office was conducted on (b)(6) 2018 at which time the treating doctor relayed that the patient had taken a systemic steroid as well as a topical steroid and the patient is at this time is 100% healed. Directions for use indicate rubber dam use is required and to use the smallest amount possible. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103653875]
Dr. Called looking for treatment advise. He used gluma on 10 of his wife's lower teeth after prepping for crowns. Her lip is swollen up, sloughing of tissue, tissue has turned brown and she is experiencing discomfort. When asked he stated that there was no isolation used and that the product was liberally applied. He stated that his wife started complaining that it was hurting her very shortly after he began to apply to the gluma. He has consulted with an oral surgeon and was advised to apply lydex which is a topical steroid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2018-00001 |
| MDR Report Key | 7376723 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-26 |
| Date Facility Aware | 2018-02-27 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-03-28 |
| 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 LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 4315 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 | 2018-03-28 |
| Catalog Number | 65872354 |
| Lot Number | K010512 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER, LLC |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, HESSEN 61273 GM 61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-28 |