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

Model Number	441601
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 sterile field and a new pack of sterile gauze was opened.Tried to remove as many loose threads as possible.Component was used in roi (b)(4) customer procedure kit number 880087014, gs00087n, lot number 82828n.

• Brand Name: DERMACEA
• Common Device Name: X-RAY SPONGES 4X4 16 PLY
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10837065
• Report Number: 3014527682-2020-00021
• Device Sequence Number: 3095141
• 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: 17061401, 17052003
• 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