| BRAND NAME | GORE-TEX DUALMESH BIOMATERIAL |
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| MANUFACTURER |
| MEDICAL PRODUCTS DIV., WL GORE & ASSOC., INC. |
| 3750 W KILTIE LN, DOCK A |
| FLAGSTAFF AZ 86001 |
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| ACCESS NUMBER | M569692 |
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| PRODUCT CODE | FTM |
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| PANEL | GENERAL AND PLASTIC SURGERY |
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| REPORT TYPE | SERIOUS INJURY |
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| DATE FDA RECEIVED | 11/10/1994 |
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| DEVICE CATALOGUE NUMBER | IDLM04 |
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| EVENT DESCRIPTION TYPE | FINAL |
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| EVENT DESCRIPTION |
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| DEVICE WAS USED TO REPAIR EVENTUAL HERNIA DEFECT IN A 64-YR-OLD MALE PT. THE SURGEON SEWED 2 DEVICES TOGETHER, SIDE BY SIDE, TO COVER THE DEFECT. POST-OPERATIVELY, THE PT WAS COMING OUT OF ANESTHESIA AND COUGHED. AT REOPERATION THE SURGEON ALLEGED THREE SUTURES HAD PULLED THROUGH ONE OF THE DEVICES. |
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