MAUDE Adverse Event Report: CONVATEC LIMITED AQUACEL - ANTIMICROBIAL AG HYDROFIBER DRESSING; DRESSING, WOUND, DRUG

Model Number 403708

Device Problems Unsealed Device Packaging (1444); Problem with Sterilization (1596)

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

Event Date 07/17/2014

Event Type  malfunction  

Event Description

It was reported product was improperly sealed and sterilized due to the sandwiched product by the sachet bag.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.Sent request for additional information.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.

• Brand Name: AQUACEL - ANTIMICROBIAL AG HYDROFIBER DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC LIMITED; unit 20, first avenue; deeside industrial park; deeside, flintshire ; UK
• Manufacturer (Section G): CONVATEC LIMITED; unit 20, first avenue; deeside industrial park; deeside, flintshire ; UK
• Manufacturer Contact: matthew walenciak, director ; unit 20, first avenue; deeside industrial park; deeside, flintshire ; UK ; 9083779293
• MDR Report Key: 4059671
• MDR Text Key: 16547489
• Report Number: 1000317571-2014-00059
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: 403708
• Device Catalogue Number: 403708
• Device Lot Number: 3JO1121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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