TOROSA

Additional Manufacturer Narrative

THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND 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, THE DATE OF IMPLANT WAS NOT PROVIDED BUT OCCURRED APPROXIMATELY ONE MONTH PRIOR TO EXPLANT. THE PATIENT EXPERIENCED FLUID LOSS ONE WEEK PRIOR TO EXPLANT. PRIOR TO THE FLUID LOSS THE PATIENTS CHIEF COMPLAINT WAS THE AESTHETIC, UPON HEALING. THE IMPLANT DEFLATED INTERNALLY AND UPON EXPLANT IT WAS NOTED THERE WAS NO SALINE IN THE IMPLANT.

Additional Manufacturer Narrative

THE FOLLOW-UP WAS CREATED TO DOCUMENT THE CONCLUSION OF THE INVESTIGATION. ONE TESTICULAR WAS RECEIVED FOR EVALUATION. IN ADDITION, A PHOTOGRAPH OF THE EXPLANTED TESTICULAR WAS PROVIDED. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED NO FUNCTIONAL ABNORMALITIES WITH THE TESTICULAR. MICROSCOPIC EXAMINATION OF THE INJECTION PORT REVEALED ONLY ONE INJECTION SITE, INDICATING A NEEDLE HAD BEEN INSERTED. THE INFORMATION RECEIVED INDICATED THAT THE DEVICE LEAKED IN-VIVO. DURING TESTING, NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENT. FURTHER EXAMINATION OF THE INJECTION PORT REVEALED ONLY ONE INJECTION SITE WAS NOTED. PRIOR TO STERILIZATION QUALITY INSERTS A BUTTERFLY NEEDLE TO PREVENT OVER PRESSURIZATION. AS ONLY ONE INJECTION SITE WAS NOTED, QUALITY CONCLUDED THAT THIS DEVICE MOST LIKELY WAS NOT FILLED PRIOR TO IMPLANT. 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.