MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

According to the initial reporter the zfen graft was explanted in (b)(6) 2020.It was reported that the patient required an additional procedure.No further information was provided.

• Brand Name: UNKNOWN
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 10871192
• MDR Text Key: 217334648
• Report Number: 3005580113-2020-00444
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2020,11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention