Alerta De Seguridad para Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads

Safety alert

2014-07-17

2014-07-17

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140717b.html

Medical device safety alert: systagenix wound management ltd. topper xtra absorbent dressing pads medical device manufacturer, systagenix wound management ltd., has issued a field safety notice (fsn) concerning topper xtra absorbent dressing pads (product code: m11121n, m11131, m11141, p55263, p55264 and p55255). the manufacturer has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection. the manufacturer advises users to immediately segregate and discontinue use of the affected products. clinicians should immediately discontinue use of the affected products, and monitor any patients who were using, or have recently used, any of the affected product for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 jul 2014.