Investigation.Initiated manufacturer's investigation.No sample returned.Review dhr.Inspect stock product.*analysis and findings.Distribution history.The complaint product was manufactured at csi in january 2020 under work order (b)(4).Manufacturing record review (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review.Incoming inspection record review not applicable to this product.Service history record.Service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history shows other complaints for this issue.Product receipt.The complaint product has not been returned to coopersurgical.Visual evaluation.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.*correction and/or corrective action.Coopersurgical decided to return manufacturing to the supplier (eis) in late 2020.Long stem gellhorns were qualified per val-20-0285 and short stem gellhorn pessaries were qualified per val-20-0289.In addition, the prints for the gellhorn pessaries were updated to reduce the durometer hardness from 60 to 45.*was the complaint confirmed? no.
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