MAUDE Adverse Event Report: AQUACEL EXTRA; DRESSING, WOUND, DRUG

Model Number	420676
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	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.
Event or Problem Description
It was reported by a nurse practitioner that a foreign body appearing to be a small worm or insect was noted in the aquacel ag+ dressing when opened.The dressing was not used on a patient.A photograph depicting the issue was provided.No further information was provided.
Additional Manufacturer Narrative
Correction: brand name: aquacel ag extra.Corrected data: initial reporter(parent): (b)(6).Batch record have been reviewed; all required specifications were met and documented within the batch record.There were no discrepancies noted in the batch record related to the reported complaint issue.The production monitoring system was reviewed and there were no issues relating to the complaint issue.Preventative maintenance was completed to schedule.Machine logs were reviewed and there were no issues relating to the complaint.No sample was received therefore it cannot be analysed and the foreign matter cannot be determined.All machines are being and revalidated as part of the manufacturing site wide scheme which should reduce the occurence of this type of issue.This issue will be monitored through the post market product monitoring review process.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 EXTRA
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 6911288
• Report Number: 1000317571-2017-00049
• Device Sequence Number: 10792113
• Product Code: FRO
• UDI-Device Identifier: 00768455127405
• UDI-Public: 768455127405
• Combination Product (Y/N): N
• PMA/510(K) Number: K121275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• 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: Nurse
• Device Expiration Date: 12/01/2019
• Device Model Number: 420676
• Device Catalogue Number: 420676
• Device Lot Number: 6M01025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1