TOROSA

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

Description of Event or Problem

A TOROSA TESTICULAR WAS RECEIVED FOR EVALUATION. AS EXAMINATION OF THE DEVICE MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF USE ERROR QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS AS TO THE REASON FOR SURGICAL INTERVENTION.

Additional Manufacturer Narrative

WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, PER NURSING IT WAS SAID, A PLACEMENT POSITION ISSUE. ONE SIDE IS SITTING HIGHER THAN THE OTHER SIDE. THERE IS NO COMPLAINT ON THE EXISTING DEVICE. THE IMPLANT WAS CHANGED BECAUSE THE POSITION OF THE ORIGINAL IMPLANT WAS INCORRECT. THERE WAS NO FAULT WITH THE DEVICE, BUT THE SURGEON MADE THE DECISION TO REPLACE THE IMPLANT. THIS WOULD BE DEEMED SURGICAL ERROR AND NOT A PRODUCT ISSUE. REVISION TO REPLACE ONE LARGE TESTICULAR.