SXPP1B429 | 合法醫療器材資訊網

2020年3月26日—ThefixationloopoftheSTRATAFIXSpiralPDSPlusDeviceshouldbedeployedbyusersfamiliarwithsurgicalprocedures,techniquesand ...

DISCLAIMER

The fixation loop of the STRATAFIX Spiral PDS Plus Device should be deployed by users familiar with surgical procedures, techniques and tissues and the use of absorbable devices before employing the STRATAFIX Spiral PDS Plus Device for wound closure, as risk of wound separation may vary with the site of application and the suture material used. Physicians should consider the quantity and quality of tissue in which the loop will be anchored. The use of this device may be inappropriate in highly vascularized tissue or fragile tissue that cannot withstand potential further tigthening/constriction within the loop. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a device for use in patients. The use of this device may be inappropriate in elderly, malnourished or debilitated patients, or in patients suffering from conditions which may delay wound healing. As with any foreign body, prolonged contact of any device with salt soluti...