MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-04 for HUTCHISON SALINE MAMMARY IMPLANT SMOOTH ROUND HSL-0340 manufactured by Biosil, Ltd.
[172229]
Deflation of the right breast implant, follow by explantation and replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320466-2000-00033 |
| MDR Report Key | 276416 |
| Date Received | 2000-05-04 |
| Date of Report | 2000-04-18 |
| Date of Event | 2000-02-17 |
| Date Facility Aware | 2000-02-17 |
| Report Date | 2000-04-18 |
| Date Reported to FDA | 2000-04-18 |
| Date Reported to Mfgr | 2000-04-18 |
| Date Added to Maude | 2000-05-09 |
| 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 | 0 |
| 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 SALINE MAMMARY IMPLANT |
| Generic Name | SALINE BREAST IMPLANT |
| Product Code | FWN |
| Date Received | 2000-05-04 |
| Returned To Mfg | 2000-04-18 |
| Model Number | SMOOTH ROUND |
| Catalog Number | HSL-0340 |
| Lot Number | S2590\1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 267548 |
| Manufacturer | BIOSIL, LTD |
| Manufacturer Address | 127 DEERDYKES VIEW WESTFIELD IND ESTATES CUMBERNAULD GLASGOW * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-04 |