MAUDE Adverse Event Report: CONVATEC LIMITED AQUACEL EXTRA 10 X 10; HYDROPHILIC WOUND DRESSING, 79NAC

Device Problems Material Disintegration (1177); Sticking (1597); Moisture or Humidity Problem (2986)

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

Event Date 07/03/2014

Event Type  Injury  

Event Description

It is reported that during the removal of the aq extra dressing the gel was found to have disintegrated into the wound bed, leaving a hard residue embedded in the slough after weeks of use.It is further reported that in order to remove the dressing, the strengthening fibers were cut and removed individually and the wound remoistened with continued treatment using aquacel extra.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Additional patient/event details have been requested, to date no details have been received.Should additional information become available a follow-up report will be submitted.Reported to the fda on august 1, 2014.Note: the actual date of event is unknown, so the date used was the date convatec became aware.

• Brand Name: AQUACEL EXTRA 10 X 10
• Type of Device: HYDROPHILIC WOUND DRESSING, 79NAC
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak,interim assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4024579
• MDR Text Key: 19970285
• Report Number: 1000317571-2014-00054
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention