SOL-MILLENNIUM

Description of Event or Problem

CUSTOMER REPORTED: DIFFICULTY PENETRATING THE SKIN. INCREASES THE PATIENT'S PAIN. LESS WELL DIRECTED AND INCREASES THE DURATION OF THE PROCEDURE. INJECTION OF THE PRODUCT IS MORE DIFFICULT. DIFFICULT TO REMOVE CHUCK. ALSO, WHEN THE NEEDLE IS USED AND INSERTED, IT IS NOT RIGID AND CURVED ENOUGH WHEN INSERTED AND ESPECIALLY WHEN THERE IS A LOT OF FATTY TISSUE. SO THERE IS A DECREASE IN THE PRECISION DURING TECHNIQUE.

Additional Manufacturer Narrative

THERE IS NO EVIDENCE OF QUALITY ISSUES ASSOCIATED WITH THIS COMPLAINT BASED ON THE ARCHIVE SAMPLE ANALYSIS. BASED ON THE DETERMINED RISK PRIORITY NUMBER, THE RESIDUAL RISK RELATED TO THE COMPLAINT IS CONSIDERED ACCEPTABLE. SOL MILLENNIUM CONTINUES TO MONITOR THIS KIND OF ISSUE. ADDITIONAL ASSESSMENT WILL BE TAKEN IF A SIGNIFICANT PATTERN EMERGES. UNCONFIRMED. THIS REPORT WAS INITIALLY SUBMITTED ON 05/20/2024. DUE TO ISSUES WITH DISPLAYING THE INITIAL SUBMISSION, THIS SUBMISSION CONTAINS BOTH INITIAL AND SUPPLEMENTAL INFORMATION

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT PREVIOUSLY SUBMITTED INFORMATION. MDR REPORT NUMBER 3014312726-2024-00232 WAS SUBMITTED IN ERROR. THE ASSOCIATED COMPLAINT INVOLVES A PRODUCT DISTRIBUTED OUTSIDE OF THE UNITED STATES, WITH NO SIMILAR DEVICE CURRENTLY MARKETED IN THE U.S. THERE WAS NO INVOLVEMENT OF SERIOUS INJURY OR DEATH.