(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.No adverse quality trends of this nature were identified during the complaint review process for the reported tray catalog number or involved tegaderm material number.If a physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.
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As reported by the user facility: reports there have been 4 to 5 patients reacting to the tegaderm dressing in the kit.Adductor canal peripheral nerve block catheters were performed for total knee replacements.All the patients expressed sensitivities to the dressing at the same areas in the upper legs.Onset was noted within a couple days of application.The symptoms of sensitivities are under the large tegaderm dressing (6 inch x 8 inch) with severe skin irritation, red inflamed macular papillary, blisters, redness, and/or tenderness.No respiratory sensitivities, distress, or intervention needed.One patient was intravenously treated with benadryl & steroids for blisters.The remaining patients were assessed by surgeons and were reassured that symptoms would go away without any treatment.
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