HEMASHIELD PLATINIUM WOWEN DOUBLE VELOUR VASCULAR GRAFT

Description of Event or Problem

SEE INITIAL MFR REPORTS # 1640201-2020-0008 AND # 1640201-2020-00010 COMPLAINT # (B)(4).

Additional Manufacturer Narrative

CORRECTED DATA BLOCK H10: THE INITIAL MFR REPORT # 1640201-2020-00008 IN RELATION WITH THE COMPLAINT (B)(4) WAS FINALLY SUCCESSFULLY RECEIVED BY FDA ON 8 APRIL 2020, AND THE MFR REPORT # 1640201-2020-00010 WAS ALSO SUCCESSFULLY RECEIVED ON 8 APRIL 2020, THEREFORE THERE ARE NOW TWO MFR REPORTS IN DUPLICATE FOR THE SAME COMPLAINT (B)(4). THIS FOLLOW UP REPORT # 1640201-2020-00010 IS DONE TO INFORM THAT THE MFR REPORT # 1640201-2020-00010 DOES NOT NEED TO BE CONSIDERED ANYMORE. ANY FOLLOW UP CONCERNING THE INVESTIGATION FOR COMPLAINT (B)(4) WILL BE COMMUNICATED WITH REFERENCE TO THE MFR REPORT # 1640201-2020-00008. WE APOLOGIZE FOR THE INCONVENIENCE CREATED BY THIS DUPLICATION.

Additional Manufacturer Narrative

THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. THE DEVICE HISTORY RECORDS REVIEW CONCLUDES THAT THERE IS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR . A VISUAL INSPECTION BY OUR QUALITY ASSURANCE (QA) SUPERVISOR IS ANTICIPATED BUT NOT YET PERFORMED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. PLEASE NOTE THAT BECAUSE WE DID NOT RECEIVE ANY ACK3 FOR THE PREVIOUS INITIAL MDR (MFR REPORT # 1640201-2020-00008) MADE FOR THIS COMPLAINT, A SECOND INITIAL MDR IS SENT.

Description of Event or Problem

COMPLAINT #(B)(4): THE PRODUCT WAS OPENED TO USE DURING SURGERY AND HAIR WAS FOUND IN THE PRODUCT. THE SURGERY WAS FINISHED WITH A NEW PRODUCT OF THE SAME MODEL THAT HE HAD. THE PRODUCT CAN BE RETURNED.