MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-21 for IMPLANT OVAL CARVING BLOCK * manufactured by Silimed Inc..
[247417]
Pt had surgery at right testicle and they received a plastic testis from silimed. Problem is that this implant is very hard, as a rock and is not made with silicon gel as it is supposed to be. Http://www. Silimed. Com/product carving_block. Html. Pt is not satisfied with the implant that is hard as a rock. Pt wants to have a regular silicon testis with silicon gel, so the texture will be the same as the original. Besides this testis has been tightened under the skin surfaces with 3 "stingiest", which cause pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025380 |
| MDR Report Key | 401136 |
| Date Received | 2002-06-21 |
| Date of Report | 2002-06-21 |
| Date of Event | 2002-06-13 |
| Date Added to Maude | 2002-06-25 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANT |
| Generic Name | OVAL CARVING BLOCK |
| Product Code | MIB |
| Date Received | 2002-06-21 |
| Model Number | OVAL CARVING BLOCK |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 3232-045 |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 390176 |
| Manufacturer | SILIMED INC. |
| Manufacturer Address | 1120 GRADER ST, STE 100 DALLAS TX 75238 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-21 |