TOROSA SALINE TESTICULAR MED

Additional Manufacturer Narrative

THE IMPLANT SURGERY HAD TWO DIFFERENT LOT NUMBERS IMPLANTED BUT IT IS UNCLEAR AS TO WHICH DEVICE WAS ON WHAT SIDE. BOTH LOT NUMBERS (6441262, 6512015) HAVE BEEN REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORTS AND CAPA REVIEW. NO TRENDS WERE NOTED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, RIGHT SCROTAL TESTICULAR IMPLANT ONLY LASTED 5 WEEKS BEFORE PARTIALLY DEFLATING. ANOTHER TESTICULAR DEVICE WAS IMPLANTED.