Mdr 1000317571-2020-00039 / device 1 of 2.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Preventive maintenance (pm) logs have been checked and all pm's were completed with no discrepancies.Affected amount: 2 pieces (pcs).Aquacel wsf 2.5x45cm was manufactured under system application product (sap) code (b)(4) and manufacturing lot number 0b01633.Lot number 0b01633 was sterilized under lot 1240104111 and released on review of results of sterilization.All the results were within specification and products were released.The production process, in process testing and packaging of products were run in accordance with process instructions (pi) for machine doyen 1.A visual inspection was performed in accordance with testing method (tm) and completed at the beginning of the order and every hour following until the order was completed.No nonconformity was registered during the manufacturing process of lot 0b01633.This is the only complaint for the affected lot registered within complaint handling system.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
|