MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 3-1/2X4 STR 10S 32 PLY; GAUZE SPONGE

Model Number	7320
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
T was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze pad.The customer reports the sponges contain loose fibers.

• Brand Name: VISTEC SPG 3-1/2X4 STR 10S 32 PLY
• Common Device Name: GAUZE SPONGE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• MDR Report Key: 5943429
• Report Number: 1018120-2016-00122
• Device Sequence Number: 698700
• Product Code: GDY
• UDI-Device Identifier: 00884527017235
• UDI-Public: 0884527017235
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2016

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: Other
• Device Model Number: 7320
• Device Catalogue Number: 7320
• Device Lot Number: 16C153062
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2016
• Initial Report FDA Received Date: 09/12/2016
• Patient Sequence Number: 1