This medical device report is filed retrospectively following fda observation number 4 received by degania medical devices pvt.Ltd.During the fda inspection of 4-7 of november 2019.The observation was related to the fact that degania medical devices pvt.Ltd.Did not establish procedures for reporting mdrs to fda as a manufacturer.Till then all complaints related to the devices produced by dmd were assessed for mdr reportability, and submitted as necessary to fda by degania silicone ltd.Another q medical devices division closely affiliated with dmd.Dmd capa number (b)(4) was issued to address the observation; one of the capa actions requires dmd to perform retrospective review of all the complaints received during 2018 and 2019 and submit to fda retrospective mdrs for the reportable events (the event initially reported to fda in the borders of recall activity; report # (b)(4).It was explained by the supplier of the sensors, that the cracks in defective thermistor tip did not appear immediately, but developed following impact of different factors like time, transportation conditions, humidity.This is the reason the in process degania tests did not detect the problem.So, degania silicone initiated or recall activity, ; report # (b)(4).
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This is retrospective submission, following re-assessment of our customer complaints during period 2018-2019.Customer's text: "according to the reporter, they had event with this specific lot when the catheter showed temperature of 34 degree celsius while under tongue probe gave 37 degree celsius." they claim there was number of similar events recently when the temperature showed by catheter was lower on few degrees than the real temperature.
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