MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-06 for SILASTIC HP SHEETING manufactured by Dow.
[21750711]
Silastic hp sheeting dow corning silastic was implanted into my rt. Temporomandibular joint in (b)(6) of 1993 to create a pseudo disc to replace the damaged one that had been damaged and explanted in may of that same year. At the time of removal the pathology report identified that i was node-positive for a foreign body giant cell reaction which destroyed the structure of my tmj within the next 4 months. I underwent my first trj with a christensen i with the pmma condylar head-tmj implants, inc. In (b)(6) of 1993.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023370 |
| MDR Report Key | 2366404 |
| Date Received | 2011-12-06 |
| Date of Report | 2011-12-06 |
| Date of Event | 1993-05-18 |
| Date Added to Maude | 2011-12-14 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | SILASTIC HP SHEETING |
| Generic Name | SILASTIC/SILICONE SHEETING |
| Product Code | MIB |
| Date Received | 2011-12-06 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DOW |
| Manufacturer Address | CORNING MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2011-12-06 |