MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-24 for MANDIBULAR HAWLEY RETAINER 0012 manufactured by Dynaflex.
| Report Number | 0001937100-2019-00003 |
| MDR Report Key | 9234253 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-24 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2019-10-24 |
| 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 | MS MAUREEN MILLER |
| Manufacturer Street | 10403 INTL PLAZA DRIVE |
| Manufacturer City | ST. ANN MO 63074 |
| Manufacturer Country | US |
| Manufacturer Postal | 63074 |
| Manufacturer Phone | 3144264020 |
| Manufacturer G1 | DYNAFLEX |
| Manufacturer Street | 10403 INTL PLAZA DRIVE |
| Manufacturer City | ST. ANN MO 63074 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63074 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANDIBULAR HAWLEY RETAINER |
| Generic Name | RETAINER |
| Product Code | DYJ |
| Date Received | 2019-10-24 |
| Model Number | 0012 |
| Catalog Number | 0012 |
| Lot Number | 882953 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNAFLEX |
| Manufacturer Address | 10403 INTL PLAZA DRIVE ST. ANN MO 63074 US 63074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-24 |