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

Model Number	441601
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2020
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 field, and a new pack of raytec was opened.Tried to remove as many loose threads as possible.The gauze was contained in roi cps, llc custom pack 880087014, lot #: 82828n, gs00087n.

• Brand Name: DERMACEA
• Common Device Name: X-RAY SPONGE 4X4 16 PLY
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11015570
• Report Number: 3014527682-2020-00023
• Device Sequence Number: 19091268
• 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): 12/15/2020

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: 17061401, 17052003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1