Internal complaint reference (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
|
On the literature review "central venous catheter-related septicaemia in paediatric cancer patients", a study was conducted on patients with central venous catheters (cvc) for chemotherapeutic agents and medicine administration.The exit side was covered with opsite flexigrid dressings and left in situ for an average period of seven days.Following change of the initial dressing, a nonocclusive melolin dressing was placed, which was changed weekly or earlier if necessary.It was reported that nineteen (19) patients experienced a septicemic episode associated with redness and exudate at exit-site.These events were treated with an unspecified antimicrobial therapy.Patients' outcome is unknown.No further information is available.
|