MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-10 for HUTCHISON SMOOTH,LOW HSL-0340 manufactured by Biosil Ltd.
[370975]
Deflation of left breast implant. Bilateral exchange with inamed devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320466-2005-00061 |
| MDR Report Key | 602601 |
| Date Received | 2005-05-10 |
| Date of Report | 2005-05-06 |
| Date Facility Aware | 2005-04-05 |
| Report Date | 2005-05-06 |
| Date Reported to FDA | 2005-05-06 |
| Date Reported to Mfgr | 2005-05-06 |
| Date Added to Maude | 2005-05-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUTCHISON |
| Generic Name | SALINE BREAST IMPLANT |
| Product Code | FWN |
| Date Received | 2005-05-10 |
| Returned To Mfg | 2005-05-06 |
| Model Number | SMOOTH,LOW |
| Catalog Number | HSL-0340 |
| Lot Number | S-6493-1 |
| ID Number | * |
| Operator | NOT APPLICABLE |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 592434 |
| Manufacturer | BIOSIL LTD |
| Manufacturer Address | 127 DEERDYKES ROAD WESTFIELD IND EST CUMBERNAULD GLASGOW * |
| 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 | 1. Required No Informationntervention | 2005-05-10 |