MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-05-03 for HERBST manufactured by Herbst.
[44278764]
Specific patient information such as weight was not provided. The patient experienced that the herbst device had encroached upon the soft tissues and caused oral lesions on the patients cheeks. The doctor removed appliance and recommended that the patient rinse with chlorhexidine. To date the patient is doing fine; however, scar tissue is now present.
Patient Sequence No: 1, Text Type: N, H10
[44278765]
Doctor alleged that patient experienced severe trauma to the cheeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184045-2016-00001 |
| MDR Report Key | 5624655 |
| Report Source | OTHER |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-14 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 2016-02-15 |
| Date Added to Maude | 2016-05-03 |
| 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. MARY LAMBERT |
| Manufacturer Street | 13931 SPRING STREET |
| Manufacturer City | STURTEVANT WI 53177 |
| Manufacturer Country | US |
| Manufacturer Postal | 53177 |
| Manufacturer Phone | 2623213670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERBST |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | EJF |
| Date Received | 2016-05-03 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERBST |
| Manufacturer Address | ALLESEE ORTHODONTIC APPLIANCES 13931 SPRING STREET STURTEVANT WI 53177 US 53177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-03 |