MAUDE Adverse Event Report: CONVATEC, PURCHASING DEPARTMENT AQUACEL; DRESSING, WOUND, DRUG

Catalog Number 412010

Device Problems Difficult to Open or Remove Packaging Material (2922); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

Unable to open dressing from the protective packaging.It was stuck to packaging.

• Brand Name: AQUACEL
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC, PURCHASING DEPARTMENT; 7900 triad center drive; suite 400; greensboro NC 27409
• MDR Report Key: 9134176
• MDR Text Key: 160565628
• Report Number: 9134176
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 412010
• Device Lot Number: 7H02556
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1