It was reported that aim of this study was to compare the healing rate of burns using honey impregnated gauze and a commercially available dressing, opsite.After initial management, patients were allotted at random to two groups.In group, sterile honey impregnated gauze was applied over the burn area after washing with normal saline and covered with pads and bandage.In group 2, the wounds, after washing with normal saline, were covered by bio-occlusive, moisture-permeable polyurethane dressing (opsite, smith and nephew, uk).Of the 46 cases, infection was found in 17, of those the dressing required changing in 5 cases between 3-5 days because of exudate oozing from underneath the dressing.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The device used in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.Probable root causes include application techniques and or a failed component.The instructions for use offers further guidance.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.No batch/lot number has been provided, therefore a review of the device history has not been possible.A complaint history review found other related failures.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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