Mdr (b)(6).Device 57 of 90.A2: sex: male, age: 73.D2a: common device name: catheter, straight.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: 1049092.Manufacturing site: 3005471919.
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End user's wife states, "3 boxes of hm14 that are stuck, glued in package".Its the end (tip area), about 1 inch in length that feels very stuck like "glued to the packaging".And he cannot remove them to use after bursting water sachet.
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