InjuryBSP
UNIPLEX® NANOLINE®
Received Jul 8, 2025 · Event occurred Nov 23, 2023
Report 9611612-2025-00028 · MDR key 22436772
Device
Generic name
Uniplex® Nanoline®
Manufacturer
Pajunk Gmbh MedizintechnologieCatalog number
001156-74
Lot number
1471
Product problems
- Break
- Break
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
(B)(4). INCIDENT OCCURRED IN BRAZIL: THE MATERIAL USED BROKE DURING THE PROCEDURE.
Additional Manufacturer Narrative
THIS CASE IS REPORTED IN RETROSPECT BASED ON A RE-EVALUATION CONDUCTED IN 2025 FOR FORMAL REASONS. THERE WAS NO PARTICULAR RISK TO PATIENTS, USERS, OR THIRD PARTIES.