NATURA

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 9618003.

Description of Event or Problem

THE CONSUMER REPORTED THAT SHE HAD BEEN FITTED WITH AN INCORRECTLY SIZED WAFER, AND DURING USE THE MOLDABLE OPENING WORE AWAY, EXPOSING HARD PLASTIC THAT CAUSED A CUT TO HER STOMA. SHE EXPERIENCED SOME BLEEDING AND SUBSEQUENTLY DEVELOPED GRANULOMAS AT THE SITE OF THE CUT. SHE DESCRIBED HER STOMA AS RED, BEEFY, AND APPEARING STRANGULATED AT THE TIME, WITH A MEASURED SIZE OF APPROXIMATELY THIRTY-TWO MM. THE EVENT LIKELY OCCURRED AROUND DECEMBER 2025. THE CONSUMER SOUGHT MEDICAL ATTENTION FROM A LOCAL NURSE BUT DID NOT REQUIRE PRESCRIPTION MEDICATION OR HOSPITALIZATION. SHE DISCONTINUED THE IMPLICATED PRODUCT AND IS CURRENTLY USING ANOTHER PRODUCT CODE, WHICH PROVIDES A BETTER FIT. SHE REPORTED NO CURRENT MEDICATIONS PRIOR TO THE EVENT, NO RELEVANT MEDICATION INFORMATION, AND NO LABORATORY TESTING. NO PHOTO IS AVAILABLE AT THIS TIME.