A complaint was reported on (b)(6) 2019 indicating that devices containing dbm putty were labeled with a volume of 10.0cc, however, when the pouches were opened for use, the syringes contained 5.0cc of dbm putty.The complainant reported that three devices displaying the same defect had been implanted.There were no reported patient complications with this event.The following mdr submissions are related to this event: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.The complainant returned three additional devices from the same lot number.Upon opening the foil pouch on one device, it was confirmed that the dbm putty was as described by the complainant.The device was labeled as containing 10.0cc of dbm putty, however, only contained 5.0cc of dbm putty.
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A complaint was reported on (b)(6) 2019 indicating that devices containing dbm putty were labeled with a volume of 10.0cc, however, when the pouches were opened for use, the syringes contained 5.0cc of dbm putty.The complainant reported that three devices displaying the same defect had been implanted.The following mdr submissions are related to this event: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.
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