MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-05-02 for GLUMA DESENSITIZER POWER GEL 66043451 manufactured by Heraeus Kulzer Gmbh.
[74175495]
(b)(6). (b)(4). This is a serious injury (as defined in 21 cfr section 803. 3) as the patientreported having an adverse reaction. Because the malfunction allegation could not beconfirmed, the cause of the adverse reaction could not be determined. This incident is being reported to maintain compliance with 21 cfr 803 and out of an abundance of caution. Directions for use indicate rubber dam use is required. The dentist did not maintain adequate isolation.
Patient Sequence No: 1, Text Type: N, H10
[74175496]
Patient complained of irritation of mucosa after treatment with gluma powergel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2017-00007 |
| MDR Report Key | 6536609 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-02 |
| Date of Report | 2017-04-12 |
| Date Facility Aware | 2017-04-12 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2015-05-31 |
| Date Added to Maude | 2017-05-02 |
| 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 | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | PHILIPP-REIS-STRASSE 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 POWER GEL |
| Generic Name | VARNISH, CAVITY |
| Product Code | LBH |
| Date Received | 2017-05-02 |
| Catalog Number | 66043451 |
| Lot Number | 010206 |
| Device Expiration Date | 2017-05-31 |
| Operator | DENTIST |
| Device Availability | * |
| Device Age | 23 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-05-02 |