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

Model Number 6640-

Device Problem Sticking (1597)

Patient Problem Skin Irritation (2076)

Event Date 06/20/2017

Event Type  malfunction  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: edward alemida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6945658
• MDR Text Key: 89198512
• Report Number: 1018120-2017-05100
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 30884521007547
• UDI-Public: 30884521007547
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1