MAUDE Adverse Event Report: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING, WOUND, DRUG

Model Number	412011
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed a product malfunction.The device was not used.Additional details have been requested but not provided to date.Should additional information become available, a follow up report will be submitted.
Event or Problem Description
The end user reported that upon opening a sealed aquacel ag surgical cover dressing, a brown object about (0.2 cm x.05 cm) in size was noted.This appeared to be an insect and several tiny brown dots were seen on the gauze pad of the dressing.The dressing was not used by the patient.A photograph was provided by the end user depicting the reported event.No further details have been provided.
Additional Manufacturer Narrative
A review of the last three (3) post monitoring reports (pmr's) for trends, indicated no trends for the reported event for this product.Historical complaint data from march 2015 to march 2017 was reviewed as it related to the reported event for product model# 412011.A total of (1) complaint, including this one, was reported.This issue will be monitored through the post market product monitoring review process.No additional details have been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

• Brand Name: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 6758634
• Report Number: 1049092-2017-00040
• Device Sequence Number: 16465288
• Product Code: FRO
• UDI-Device Identifier: 00768455124299
• UDI-Public: 768455124299
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: 412011
• Device Catalogue Number: 412011
• Device Lot Number: 7C05140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1