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

Model Number	6640-
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported when the dressing was removed, skin was coming off as well.The patient was not harmed and no medical intervention or treatment was required.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer reported when the dressing was removed, skin was coming off as well.The patient was not harmed and no medical intervention or treatment was required.¿ no lot number was provided.A review of the device history report (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehen ive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KENDALL
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 6945658
• Report Number: 1018120-2017-05100
• Device Sequence Number: 718363
• Product Code: NAD
• UDI-Device Identifier: 30884521007547
• UDI-Public: 30884521007547
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 02/28/2019
• Device Model Number: 6640-
• Device Catalogue Number: 6640-
• Device Lot Number: 17C032062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 08/08/2018
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 08/01/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1