DURAHESIVE ACCORDION FLANGE

Description of Event or Problem

THE REPORTER STATED THAT THEY HAD USED THE ACCORDION FLANGE WITH DURAHESIVE FOR COLOSTOMY MANAGEMENT FOR APPROXIMATELY FOUR YEARS WITHOUT PREVIOUSLY EXPERIENCING ISSUES. THE REPORTER NOTED THAT THE MOST RECENTLY RECEIVED PRODUCT HAD A DIFFERENT BOX APPEARANCE, INDICATING A CHANGE IN PACKAGING. THE REPORTER ALSO OBSERVED THAT THE EXPIRATION DATE ON THE NEWLY RECEIVED PRODUCT WAS SIGNIFICANTLY SHORTER THAN EXPECTED, ESTIMATING THE SHELF LIFE TO BE APPROXIMATELY THREE YEARS COMPARED TO THE FIVE YEARS THEY WERE ACCUSTOMED TO. UPON USE OF THE NEWLY PACKAGED PRODUCT, THE REPORTER STATED THAT THE INTERIOR DURAHESIVE MATERIAL BEGAN TO DETERIORATE PREMATURELY. THE MATERIAL WAS DESCRIBED AS ERODING AND FALLING APART, WHICH RESULTED IN LEAKAGE. THE REPORTER INDICATED THAT THE PRODUCT DID NOT MAINTAIN INTEGRITY DURING WEAR TIME AS EXPECTED AND FURTHER SPECULATED THAT THE NEW PACKAGE WRAPPING MAY HAVE CONTRIBUTED TO THE OBSERVED DETERIORATION. THE REPORTER ALSO INDICATED THAT THIS WAS NOT AN ISOLATED OCCURRENCE, STATING THAT THE ISSUE WAS EXPERIENCED WITH PRODUCTS FROM FIVE DIFFERENT LOT NUMBERS. PT CODE: 4582. DEVICE CODES: 1177, 1354, 2975. REF REPORTS: MW5186628, MW5186629, MW5186630, MW5186631.