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

Model Number 420642

Device Problems Material Fragmentation (1261); Sticking (1597); Material Deformation (2976)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It is reported that while testing the aquacel ag dressing on pt's wound the aquacel ag separated from foam and gel residue stayed in wound.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

• Brand Name: AQUACEL FOAM
• Type of Device: HYDROPHILIC WOUND DRESSING
• Manufacturer (Section D): CONVATEC INC.; skillman NJ 08558
• Manufacturer Contact: matthew walenciak, interim ass di ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3908669
• MDR Text Key: 4496034
• Report Number: 1049092-2014-00169
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420642
• Device Catalogue Number: 420642
• Device Lot Number: 2249606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• 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