MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-19 for FORSUS FATIGUE RESISTANCE SPRING manufactured by 3m Unitek.
[4082352]
3m unitek forsus fatigue resistance spring used in oral cavity to push the lower jaw ahead has weak niti coil spring. This spring is reported to break recently in few pts causing ulceration in cheek mucosa. Reason for use: used for orthodontic correction of retrognathic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033043 |
| MDR Report Key | 3486464 |
| Date Received | 2013-11-19 |
| Date of Report | 2013-11-18 |
| Date Added to Maude | 2013-11-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORSUS FATIGUE RESISTANCE SPRING |
| Generic Name | FORSUS SPRING |
| Product Code | ECO |
| Date Received | 2013-11-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-19 |