MAUDE Adverse Event Report: COVIDIEN KENDALL

Model Number	6641
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 06/14/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported greater adherence than normal.It was difficult to remove; causing a laceration on the skin of the patient's hand.The customer further reports there was no medical intervention as a result.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KENDALL
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 6640255
• Report Number: 1018120-2017-05045
• Device Sequence Number: 1049051
• Product Code: KNT
• UDI-Device Identifier: 30884521007035
• UDI-Public: 30884521007035
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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 Expiration Date: 10/31/2018
• Device Model Number: 6641
• Device Catalogue Number: 6641
• Device Lot Number: 16L087762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 09/07/2017
• Patient Sequence Number: 1
• Patient Age: 73 YR