MAUDE Adverse Event Report: COVIDIEN DERMACEA; X-RAY 4X4 SPONGE 16PLY

Model Number	441601
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Raytec gauze is fraying and leaving threads on sterile field.There was patient contact.Raytec was removed from the field and new sterile pack of raytec was opened.Tried to remove as many loose threads as possible.Raytec was contained within roi cps, llc custom procedure kit 880092020, or00092t, lot 83111t.

• Brand Name: DERMACEA
• Common Device Name: X-RAY 4X4 SPONGE 16PLY
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10838716
• Report Number: 3014527682-2020-00020
• Device Sequence Number: 16917837
• Product Code: GDY
• UDI-Device Identifier: 10884527021239
• UDI-Public: 10884527021239
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 441601
• Device Catalogue Number: 441601
• Device Lot Number: 17063004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1