MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-17 for NOT APPLICABLE manufactured by .
[2816611]
Pt received custom made repositioning splint to help alleviate tmd symptoms. After wearing the device for 3 days the pain became so severe the pt had to stop wearing it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026223 |
| MDR Report Key | 2664470 |
| Date Received | 2012-07-17 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-03-12 |
| Date Added to Maude | 2012-07-24 |
| 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 | 0 |
| 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 | NOT APPLICABLE |
| Generic Name | CUSTOM MADE TMJ REPOSITIONING SPLINT |
| Product Code | LQZ |
| Date Received | 2012-07-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-17 |