TOROSA SALINE TESTICULAR MED

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. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF 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, THE PATIENT UNDERWENT REMOVAL OF HIS LEFT TESTICLE DUE TO LEFT TESTICULAR TUMOR. THE PATIENT HAD A PROSTHESIS PLACED AT THE TIME OF REMOVAL. SURGEON WAS NOTIFIED POSTOPERATIVELY THAT THE IMPLANTED PROSTHESIS HAD FAILED AND HAD DEFLATED.