The manufacturer, (b)(4) was notified of the complaint reported with the information provided from the customer (item# 3077v2 / lot#70101q) on october 10,2017.However, on november 6, 2017, the customer retracted the submission of their initial product information and was not able to provide a lot# along with the replacement information submitted (item# 4631v2) for the reported device.Without the lot# or a defect device to examine for physical investigation, the manufacturer could not conduct a proper investigation on the reported information provided.The following blocks were corrected within this follow-up mdr report: the customer retracted initial information (item#3077v2 and lot#70101q) submitted to the importer (b)(4).However, the replacement item# (4631v2) provided by the customer requires a different 'common device name'.Therefore the information in this field will be change from epidural needle, product code: bsp to spinal needle, product code: bsp.Manufacturer name, city, and state information has been changed from (b)(4) to (b)(4).This change came as an update within the fda 'establishment registration & device listing' for (b)(4) co., ltd.The current address listed was for the main office instead of the actual manufacturer facility address.Therefore, the correct address is (b)(4) for the manufacturer name/address.Catalog#, the customer retracted the initial reporting of item# 3077v2 to report item# 4631v2 as the replacement.Therefore, the correct item# will be listed as 4631v2 in this field.Lot#, the customer retracted the initial reporting of the lot# 70101q and did not provide replacement lot #, therefore, this field will remain blank in this follow-up report.Expiration date, due to the customer retracting the initial reporting of the lot# without a replacement, the exact expiration date for the reported device cannot be determined.Therefore, this field will remain blank in this follow-up report.Unique identifier (udi#), due to the customer retracting the initial item# reported, the replacement item# does not correlate with the initial udi# recorded for this event.Therefore, the udi# will be updated from (b)(4) as reported in this mdrs initial report to (b)(4) to reflect the replacement item#.After further communication with the customer, it was confirmed that the reported device was not available for evaluation; therefore, the selection will be changed from 'no information' to 'no'.After further communication with the customer, it was confirmed that the end-user's information would not be disclosed for communication; therefore, the distributer's information for the best person to contact as the 'initial reporter'.Manufacturer name/address information has been changed from (b)(4) to (b)(4).This change came as an update within the fda 'establishment registration & device listing' for (b)(4) co., ltd.The current address listed was for the main office instead of the actual manufacturer facility address.Therefore, the correct address is (b)(4) for the manufacturer name/address.Due to the lack of information and no defect device available for examination, this complaint file was closed on november 10, 2017 and therefore, will consider this mdr as closed.
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