MAUDE Adverse Event Report: COVIDIEN KERLIX; DRESSING,WOUND,OCCLUSIVE

Model Number	3332
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 09/03/2017.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reports that the rolls are counted and logged into the wound; however, upon opening, the surgeon unraveled the roll to discover that it consisted of two ends of gauze strip tied roughly together, with many frayed loose fibers.The kerlix bandage roll was opened for use inside a right calf wound.The customer further reports that there was no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
This is a non reportable event based on the incorrect coding used.The gauze used was not a surgical gauze and based on the information provided by the customer the fraying was noticed prior to use.The coding has been corrected to non surgical gauze and a correction will be made as non-reportable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KERLIX
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 6840719
• Report Number: 1018120-2017-05088
• Device Sequence Number: 750794
• Product Code: NAD
• UDI-Device Identifier: 20884521020037
• UDI-Public: 20884521020037
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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 Expiration Date: 06/01/2021
• Device Model Number: 3332
• Device Catalogue Number: 3332
• Device Lot Number: 16F162462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 09/03/2017
• Supplement Report FDA Received Date: 03/19/2018
• Patient Sequence Number: 1