| BRAND NAME | GORE-TEX DUAL MESH BIOMATERIAL |
|---|
| MANUFACTURER |
| MEDICAL PRODUCTS DIV. W.L. GORE & ASSOCIATES, INC. |
| 3750 W KILTIE LN, DOCK A |
| FLAGSTAFF AZ 86001 |
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| ACCESS NUMBER | M577004 |
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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 | 12/09/1994 |
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| DEVICE CATALOGUE NUMBER | 1DLM04 |
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| EVENT DESCRIPTION TYPE | PRELIMINARY |
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| EVENT DESCRIPTION |
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| THE DEVICE WAS REMOVED DUE TO AN ALLERGIC REACTION. THE DEVICE WAS IMPLANTED LAPAROSCOPICALLY, IN A 68-YR-OLD FEMALE, TO REPAIR AN INCISIONAL HERNIA. IMPLANT DURATION WAS APPROX 13 DAYS. |
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