MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-31 for GLUMA DESENSITIZER 65872354 manufactured by Heraeus Kulzer Gmbh.
[53660125]
(b)(4). (b)(4) has made several attempt to collect additional information. On 8/4/2016- called and left a message stating we needed to speak with (b)(6). (original caller) in regards to this allegation. Asked for a return call. On 8/19/2016-spoke with (b)(6). She explained this was not a patient that they treated but that of another provider. A dds had contact them in hopes to obtain medical advice for treating the patient. The medical center was not certain as to what/if any treatment was recommended or administered to the patient. She was not able to provide me with any additional information including the exact name of the product. She would not release any of the treating dds information so they heraeus kulzer could contact them directly. My contact information was given and requested that she please give it to the provider for them to contact me as additional information was needed. On 8/25/2016- contacted the medical center to follow up on whether or not the contact information had been given to the treating dds. I was informed it had been. The medical center at this time had no additional information. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[53660126]
A medical center contacted us after a treating dds called seeking medical advice for a patient who developed a swollen lip after the use of gluma. The medical center was calling on behalf of the dds and was not able to provide any additional information including the exact name of the product used, application, duration of application, isolation technique and so on. The contacting medical center would not release the treating dds's information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2016-00016 |
| MDR Report Key | 5919766 |
| Report Source | OTHER |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-30 |
| Date of Event | 2016-08-02 |
| Date Facility Aware | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Date Added to Maude | 2016-08-31 |
| 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 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 |
| Generic Name | ENAMEL DESENSITIZER |
| Product Code | LBH |
| Date Received | 2016-08-31 |
| Catalog Number | 65872354 |
| 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 | 2016-08-31 |