MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-06-22 for manufactured by .
| Report Number | 9614385-2005-00067 |
| MDR Report Key | 617007 |
| Report Source | 08 |
| Date Received | 2005-06-22 |
| Date Mfgr Received | 2005-05-11 |
| Device Manufacturer Date | 1999-10-01 |
| Date Added to Maude | 2005-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 127 DEERDYKES VIEW WESTFIELD IND ESTATE |
| Manufacturer City | CUMBERNAULD, SCOTLAND G68 9HN |
| Manufacturer Country | * |
| Manufacturer Postal | G68 9HN |
| Manufacturer Phone | 36780780 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FWN |
| Date Received | 2005-06-22 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 592434 |
| Baseline Brand Name | HUTCHISON |
| Baseline Generic Name | SALINE BREAST IMPLANT |
| Baseline Model No | SMOOTH,LOW |
| Baseline Catalog No | HSL-0340 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-22 |