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BRAND NAMEBARD MARLEX MESH
MANUFACTURER
BARD VASCULAR SYSTEMS DIVISION
129 CONCORD ROAD - P.O. BOX 1081
BILLERICA MA 01821
ACCESS NUMBERM569017
PRODUCT CODEFWM
PANELGENERAL AND PLASTIC SURGERY
REPORT TYPESERIOUS INJURY
DATE FDA RECEIVED11/04/1994
DEVICE CATALOGUE NUMBER011266
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
MESH WAS USED TO ENFORCE A LARGE ABDOMINAL WOUND. THE WOUND WAS THE RESULT OF RESULT OF A GASTRIC BYPASS PROCEDURE. WHILE THE DOCTOR WAS SUTURING THE MESH IN PLACE, A SMALL TEAR OCCURRED. THE DOCTOR REPAIRED THE TEAR WITH SUTURES AND COMPLETED THE PROCEDURE. TWO DAYS LATER, ANOTHER TEAR WAS OBSERVED IN THE MESH. ANOTHER MESH PATCH WAS USED TO REPAIR AND SUPPORT THE ORIGINAL MESH PATCH.
CLOSEOUT TEXT
THESE TYPES OF EVENTS USUALLY INVOLVE KNOWN COMPLICATIONS THAT DO NOT JUSTIFY IMMEDIATE ACTION OR REVIEW OF THE INDIVIUAL REPORT. HOWEVER, THE EVENT AND OTHER SIMILAR EVENTS ARE AVAILABLE FOR FURTHER STATISTICAL ANALYSIS AND MONITORING.
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