MAUDE Adverse Event Report: CONVATEC INC AQUACEL SURGICAL HYDROFIBER SURGICAL COVER; DRESSING, WOUND, HYDROPHILIC

Device Problems Device Operates Differently Than Expected (2913); Free or Unrestricted Flow (2945)

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

Event Type  malfunction  

Event Description

It was reported that holes were found on the aquacel surgical dressing during wear.The end user had used the dressing for a total of seven days before the holes were discovered.It was also reported that there were changes in consistency over the areas where the device absorbs liquid thus the device was not completely saturated during use.

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.No patient complications were reported as a result of this event.Should additional information become available a follow-up report will be submitted.This complaint issue occurred on (2) separate cases.A separate 3500a form has been completed for the other case.(b)(4).

Manufacturer Narrative

No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received on september 24, 2015 confirming the complainant's name.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: AQUACEL SURGICAL HYDROFIBER SURGICAL COVER
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4898330
• MDR Text Key: 6831220
• Report Number: 1049092-2015-00375
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• 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