Date of event: information was not provided.Device lot number was not provided.Lot number was not provided.Therefore, manufacture date unknown.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code (gsc) of szp and reported failure.No trends were observed.3m will continue to monitor.Test results confirm the biocompatibility of nexcare¿ flexible clear tape for their intended use.In addition to performing clinical studies, 3m¿ monitors its medical devices with manufacturing controls, including in-process specifications, release specifications and testing.
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A female customer (age unspecified) reported an incident regarding the nexcare¿ flexible clear first aid tape.On an unspecified date, the bandage was applied over another brand of bandage covering a draining sore (type of drainage was not reported) on her ankle (exact location was reported).A couple of days later, she allegedly broke out in a rash on her stomach, chin, arms and the back of her ears.She alleged her lower arm was also slightly swollen.On an unspecified date, the doctor prescribed triamcinolone acetonide ointment usp 0.1% for the rash.No allergies, medical history or intervention reported.
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