MAUDE Adverse Event Report: CARDINAL HEALTH, INC. XEROFORM; DRESSING, WOUND, DRUG

Model Number	8884433605
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Xeroform gauze was identified to be packaged unsterile.A thread that was attached to the gauze was sealed outside the unopened package.

• Brand Name: XEROFORM
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; building 5; mansfield MA 02048
• MDR Report Key: 8369554
• Report Number: 8369554
• Device Sequence Number: 11037458
• Product Code: FRO
• UDI-Device Identifier: 30884527014952
• UDI-Public: (01)30884527014952
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/20/2019
• Report Date (Section F): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8884433605
• Device Catalogue Number: 8884433605
• Device Lot Number: 811507
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/20/2019