MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-23 for SILASTIC SHEETING manufactured by Dow Corning.
[21262058]
Had temporary silastic sheeting implanted in tmj joints in 2004. The silastic has fragmented and discs are failing. Oral surgeon who implanted temporary sheeting decided not to remove it, so it is still in today. Developed osteochondroma (tumor) on left side of the joint. Also suffering from swallowing issues, nodules in lungs, chemical sensitivity, severe migraines, skull pain, movement disorders, nerve impingement issues, kidney failure and balance problems. On disability due tot all of these medical issues
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031621 |
| MDR Report Key | 3314127 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-08-22 |
| Date of Event | 2013-08-22 |
| Date Added to Maude | 2013-08-30 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| 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 | SILASTIC SHEETING |
| Generic Name | SILASTIC SHEETING |
| Product Code | MDA |
| Date Received | 2013-08-23 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DOW CORNING |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2013-08-23 |