| BRAND NAME | BARD MARLEX MESH |
|---|
| MANUFACTURER |
| BARD VASCULAR SYSTEMS DIV. C.R. BARD, INC. |
| 129 CONCORD RD. P.O. BOX M |
| BILLERICA MA 01821 |
|
| ACCESS NUMBER | M569107 |
|---|
| PRODUCT CODE | FTM |
|---|
| PANEL | GENERAL AND PLASTIC SURGERY |
|---|
| REPORT TYPE | SERIOUS INJURY |
|---|
| DATE FDA RECEIVED | 11/04/1994 |
|---|
| DEVICE CATALOGUE NUMBER | 011266 |
|---|
| EVENT DESCRIPTION TYPE | PRELIMINARY |
|---|
| EVENT DESCRIPTION |
|---|
| DEVICE WAS USED TO ENFORCE A LARGE ABOMINAL WOUND. THE WOUND WAS THE RESULT OF A GASTRIC BYPASS PROCEDURE. WHILE THE DR WAS SUTURING THE MESH IN PLACE A SMALL TEAR OCCURRED. THE DR REPAIRED THE TEAR WITH SUTURES AND COMPLETED THE PROCEDURE. TWO DAYS LATER ANOTHER TEAR WAS OBSERVED IN THE MESH. NO FURTHER SURGICAL INTERVENTION WAS REPORTED. |
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