| BRAND NAME | MARLEX MESH |
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| MANUFACTURER |
| DAVOL, INC. |
| P.O. BOX 8500 |
| CRANSTON RI 02920 |
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| ACCESS NUMBER | M751109 |
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| PRODUCT CODE | FTM |
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| PANEL | GENERAL AND PLASTIC SURGERY |
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| REPORT TYPE | DEATH |
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| DATE FDA RECEIVED | 04/01/1996 |
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| EVENT DESCRIPTION TYPE | FINAL |
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| EVENT DESCRIPTION |
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| A PT UNDERWENT A LAPAROSCOPIC EXTRAPERITONEAL HERNIA REPAIR. FIVE DAYS POST-OP PT DEVELOPED FLU-LIKE SYMPTOMS. SEVEN DAYS POST-OP PT WENT INTO RENAL FAILURE. NINE DAYS POST-OP PT DEVELOPED ARDS. PT UNDERWENT AN EXPLORATORY LAPAROTOMY LOOKING FOR INFECTION. SURGEON OPENED UP THE GROIN AND THE SURGICAL MESH APPEARED TO BE "REJECTED" AND WAS IN A POOL OF "UGLY" FLUID. CULTURES TAKEN WERE NEGATIVE. THE PT WENT ON TO DIE. |
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