Common device name ¿ dressing, wound, occlusive.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Per the information for use (ifu), the maximum recommended wear time for this product is up to seven (7) days.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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As stated in the batch records of bulking lots manufactured on the extruder laminating 10 machine, materials were used as indicated in the bill of material (bom), a line clearance was performed at the start of manufacturing operation and at the end of the process; furthermore, periodic reviews of line clearance requirements are performed at the start-up of each shift and after electrical or major mechanical adjustments.On (b)(6)2018 , an extraordinary maintenance was performed to the extruder laminating 10 machine, while running the lot number 8c04850 (item 1003413) by the maintenance area, related to ¿failure in the cooling tower¿.However, this failure does not impact the properties of the products based on quality testing results.The adhesives test and the ¿strip to strip t-peel was performed for the first piece or after machine stop with satisfactory results.The required visual inspection testing was performed per hours.Dimensions and product characteristics testing were performed every half hour; the overall thickness was found in range.All quality and manufacturing testing were considered acceptable and process parameters were properly set as documented.Finally, inspections are performed by quality to the packaged product and all results were satisfactory.On(b)(6)2019 , a query was performed to each individual impacted lot (final and bulking lots) in the system to confirm if any local event, such as rework or nonconformance occurred during the manufacturing process of those lots regarding to the same failure mode reported.As result, not events were found related to this failure mode.On (b)(6)2019 , a query was run from january 01, 2019 to december 31, 2018 to cover the full year in the system looking for customers reporting complaints, associated to the reported malfunction in the doyen a machine.As result, a total of six (06) complaints were found associated to the mentioned failure mode (including the ones triggering this nonconformance).No negative trend is observed, based on the total quantity manufactured of impacted final lots.Based on the initial assessment performed through revision of the batch records documentation, pictures provided by customers in complaints reported and process evaluation, this event could not be confirmed due to samples were not available to measure dressing dimensions, could not be confirmed if products were used during the recommended period as established in the instruction for use.Recommended medical instructions were properly followed for the product 8c05035.No local events were found related to manufacturing requirements as per batch records review of bulking and final lots.However, a defect notification was given to quality and manufacturing assigned to the extruder laminating 10 machine to make them aware of complaints reported by customers.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: (b)(4).Manufacturing site: (b)(4).
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