NATURA
Received May 29, 2026
Report 9618003-2026-00991 · MDR key 25340978
Device
Product problems
- Malposition of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE 2 OF 3. 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 END USER REPORTED THAT HE HAD BEEN EXPERIENCING AN ONGOING ISSUE OVER THE PAST THREE MONTHS. HE STATED THAT IN EACH BOX, HE OFTEN FOUND ONE OR TWO SKIN BARRIERS THAT WERE OFF-CENTER. HE HAD ATTEMPTED TO USE THESE DEFECTIVE BARRIERS, BUT EACH TIME HE DID SO, HE EXPERIENCED LEAKAGE. THE OPENINGS WERE OFF-CENTERED, WHICH MADE THE SKIN BARRIERS UNUSABLE. NO PHOTO WAS AVAILABLE AT THIS TIME.