Mdr (b)(4)./ device 4 of 63.Common device name ¿ dressing, wound, occlusive.Initial reporter name and address: (b)(6).As per the information provided by complainant, for the issue dressing too sticky, the imdrf med.Dev.Prob.Code: (b)(4).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).
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It was reported that dressing was much more difficult to remove from skin when changing dressings than it used to be.The dressing got stuck extremely strongly, sometimes only be removed in pieces for which more use of adhesive remover required significantly.Along with the company's dressing, the treatment regimen of the practitioners provided for the additional use of a foil bandage to minimize the rolling up of the bandage edges of dressing so far with complete satisfaction.Although the products were heavier and more time-consuming to use, the customer continued to use the products before and after reporting the detected quality change as they saw no risk to the patients.According to the customer, he reported this issue for several uses and due to the accumulation of difficult handling of the product.The difficulty in detaching from the skin was independent of the skin type.The product was used for two to four days.There was no harm reported.The photographs depicting the issues were received from the complainant.
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