NUT

Description of Event or Problem

DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011. RESOLVING HAEMATOMA WAS IDENTIFIED AND WASHED OUT COPIOUSLY. TISSUES SAMPLES WERE TAKEN AND SENT FOR MICROSCOPY CULTURE AND SENSITIVITY. THE WOUND WAS CLOSED. THIS IS # 38 OF 50 REPORTS FOR THE SAME EVENT.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS DEVICE WAS NOT RETURNED AND LOT NUMBER WAS NOT PROVIDED.