MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-08-11 for GLUMA DESENSITIZER POWERGEL 66043451 manufactured by Heraeus Kulzer Gmbh.
[51821351]
(b)(4). Athough we have not established that the device caused or contributed to to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative: according to the directions for use gluma powergel the user should protect mucous membranes from contact with the product using a rubber dam.
Patient Sequence No: 1, Text Type: N, H10
[51821352]
The office's hygienist applied this product to a total of 3 patients during the beginning and middle of (b)(6). Of the 3 patients, 2 of the patients experienced tissue burns. There was no isolation used during the application process. I informed the office member reporting incident that the dfu states that rubber dam isolation is needed. There was no additional treatment needed or performed by the dental staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2016-00014 |
| MDR Report Key | 5868004 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-08-11 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-07-01 |
| Date Facility Aware | 2015-07-15 |
| Date Mfgr Received | 2016-07-15 |
| Date Added to Maude | 2016-08-11 |
| 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 | MRS. AMBER BROWN |
| Manufacturer Street | 4315 LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995411 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | PHILIP-REIS-STRABE 8/13 |
| Manufacturer City | WEHRHEIM, GM G-61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | G-61273 |
| 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 | 2016-08-11 |
| Catalog Number | 66043451 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIP-REIS-STRABE 8/13 WEHRHEIM, GM D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-11 |