MAUDE Adverse Event Report: CONVATEC INC. AQUACEL FOAM HYDROFIBER DRESSING, STERILE; DRESSING,WOUND,HYDROPHILIC

Model Number 420619

Device Problems Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)

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

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the dressing came away from the area in which it had been applied in less than one hour after it had been applied, therefore an alternative dressing had to be used to treat the wound.No patient complications were reported as a result of this event.

• Brand Name: AQUACEL FOAM HYDROFIBER DRESSING, STERILE
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5089606
• MDR Text Key: 26234725
• Report Number: 1049092-2015-00544
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1