Model Number UPC#311917195209 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Skin Irritation (2076)
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Event Type
Injury
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Manufacturer Narrative
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As of (b)(6) 2020 unused retained samples of the same lot as the product reported and returned product were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening with no issues noted.
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Event Description
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On the initial report of 03/31/2020 consumer stated that product caused an allergic reaction.On cir received on 04/07/2020 consumer added was prescribed antibiotics, neosporin & benadryl; and stated that still has a faded mark of the bandage and itchiness on the affected area.
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Search Alerts/Recalls
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