Correction (g1) - contact office address: (b)(4).Lot 0d04898 was manufactured on 5/13/2020 in the convex 1 pc manufacturing line, with a total of (b)(4) market units.On 31/may/2021, compliance engineer id 6053 performed a batch record review, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, under sap material 1004089, icc code 650831 and manufacturing order (b)(4).The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according the process instruction pi21-076.The process requirements results were documented in the manufacturing records mr21-076.In addition, the batch record of bulk lot 0d03915, manufactured in the elc6 manufacturing line, was reviewed and no issues were found; the lot ran according to sap material 1002590, all the testing results were found satisfactory.The process was run according to process instruction pi22-057, documented in mr22-057.Batch record review supports that no issues regarding the failure mode reported were identified.On 31/may/2021 a complaint search for lot 0d04898 and malfunction code ost-pmc1.16 / ost-pmc01.16 inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer) was carried out and as a result, no additional complaints were found; therefore, no trend is observed.As per complaint manufacturing investigation procedure wi-0359, version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed (either by photo, video or sample provided by the customer, or as a result of the batch record review) and no potential trend is identified.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
|