MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-06-20 for GLUMA DESENSITIZER 65872354 manufactured by Kulzer, Llc.
[111762674]
(b)(4). Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined. The incident is being reported to be compliant with 21 cfr part 803 and out of an abundance of caution. Directions for use indicate that isolation must be maintained in order to protect the soft tissue. Isolation was not maintained.
Patient Sequence No: 1, Text Type: N, H10
[111762675]
A (b)(6) female patient had gluma applied 6 times without use of isolation or rinsing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2018-00003 |
| MDR Report Key | 7618666 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-06-20 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-30 |
| Date Facility Aware | 2018-05-30 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-20 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RITA ROGERS |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | KULZER, LLC |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM, HESSEN 61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 61273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUMA DESENSITIZER |
| Generic Name | AGENT, TOOTH BONDING, RESIN |
| Product Code | KLE |
| Date Received | 2018-06-20 |
| Catalog Number | 65872354 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2018-06-20 |