MAUDE Adverse Event Report: CONVATEC LIMITED AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE

Model Number 403771

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2013

Event Type  Injury  

Event Description

Per the end user, the wrong size dressing was in the box.No further information is available.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of evaluations or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trends.Batch record was reviewed, all checks were carried out and the dimensions were manufactured to specification.The sample in the batch record was measured and found to meet specification.

• Brand Name: AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE
• Manufacturer (Section D): CONVATEC LIMITED; unit 20, first avenue; deeside industrial park; deeside, flintshire ; UK
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4132817
• MDR Text Key: 4945723
• Report Number: 1000317571-2014-11341
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/29/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2014
• Device Model Number: 403771
• Device Lot Number: 2H00359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2013
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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): Other