Product complaint # (b)(4).Component code: (b)(4) device not returned.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: was there any hole, tear, or puncture that compromises sterility.Yes.Any open or incomplete seal?.No.Any ease or difficulty in removing the product or component of the product from the packaging that did not compromised its integrity/sterility? na.Do you have a photo for visual analysis? no.Did the packaging look damaged? sometimes yes, sometimes no.Where there any quality issues noted prior to the packaging being handled? in some instances the packaging looks wrinkled or as if it had been compressed or crushed.Other times the packaging looks to be in good order and then the staff would find micro holes in the packaging after the item was opened to the sterile field.Was the outer case that the package arrived in damaged? the outside packaging/master pack often appears to be in good order with no obvious signs of damage.Was the packaging torn prior to opening of the package? no, the item was not torn.Where did you receive the product from (ethicon, distributor, etc)? not sure.Will the device be returned? if yes, to whom should a shipper kit be sent to? please include full name and address.Na.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? are there samples available to be returned for evaluation? event related to mw # 2210968-2021-07757, mw # 2210968-2021-07758, mw # 2210968-2021-07759, mw # 2210968-2021-07760, mw # 2210968-2021-07761.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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