| BRAND NAME | PROLENE MESH |
|---|
| MANUFACTURER |
| ETHICON, INC. |
| ROUTE 22 WEST |
| SOMERVILLE NJ 08876 |
|
| ACCESS NUMBER | M522468 |
|---|
| PRODUCT CODE | FTM |
|---|
| PANEL | GENERAL AND PLASTIC SURGERY |
|---|
| REPORT TYPE | SERIOUS INJURY |
|---|
| DATE FDA RECEIVED | 06/10/1994 |
|---|
| EVENT DESCRIPTION TYPE | PRELIMINARY |
|---|
| EVENT DESCRIPTION |
|---|
| FOLLOWING A VENTRAL REPAIR, POST-CHOLECYSTECTOMY PROCEDURE, PT WAS HOSPITALIZED FOR A WK WITH SEVERE NAUSEA AND DIARRHEA. DR ATTRIBUTES AN ALLERGIC REACTION TO PRODUCT AS A POST-OP COMPLICATION FOLLOWING REMOVAL OF SILICONE GEL MAMMARY IMPLANTS. |
|
|
