MAUDE Adverse Event Report: CONVATEC INC

Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Aquacel/aquacel ag - surgical cover dressings; dressing,wound,hydrophilic.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional information has been requested, however to date no additional information has been received.The lot number was not provided.Therefore, we are unable to determine the specific manufacturing site.Two (2) potential manufacturing site numbers are listed below.Should additional information become available, a follow-up report will be submitted.Reporting site: (b)(4); manufacturing site: (b)(4).

Event Description

It was reported the aquacel surgical cover dressing is difficult to remove in approximately eighteen to twenty (18-20) patients.She said they remove the dressing by pulling the dressing like you would taffy and then roll the remainder of the dressing off.Dressings were applied to knee and hip incisions.The dressing is in place between three to seven days.No photo was provided.

• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 8160953
• MDR Text Key: 130344626
• Report Number: 1049092-2018-00727
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WOUND CARE-UNKNOWN SURGICAL COVER DRESSI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1