MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-10 for GLUMA DESENSITIZER POWERGEL 66043451 manufactured by Kulzer Gmbh.
[82460323]
(b)(4). This is a serious injury (as defined in 21 cfr section 803. 3). As the patient reported having an adverse reaction. Because the malfunction allegation could not be confirmed, 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. Isolation of the patient's soft tissue was inadequate.
Patient Sequence No: 1, Text Type: N, H10
[82460324]
Dentist applied gluma desensitizer over female patient's entire mouth, allowing patient to close on suction and not maintaining isolation from soft tissue,
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2017-00011 |
| MDR Report Key | 6785961 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-10 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-27 |
| Date Facility Aware | 2017-06-28 |
| Date Mfgr Received | 2017-06-28 |
| Date Added to Maude | 2017-08-10 |
| 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. RITA ROGERS |
| Manufacturer Street | LEIPZIGER STRASSE 2 |
| Manufacturer City | HANAU, 63450 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63450 |
| Manufacturer G1 | KULZER GMBH |
| Manufacturer Street | LEIPZIGER STRASSE 2 |
| Manufacturer City | HANAU, 63450 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 63450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUMA DESENSITIZER POWERGEL |
| Generic Name | VARNISH, CAVITY |
| Product Code | LBH |
| Date Received | 2017-08-10 |
| Catalog Number | 66043451 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-10 |