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

Model Number	420676
Medical Device Problem Codes	Material Disintegration (1177); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2017
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 information has been requested, however to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
It was reported by a nurse that the dressing disintegrated after seven days of use on the patients right leg/foot area.Photos were included.No further details have been provided.
Additional Manufacturer Narrative
Updated data: brand name: aquacel ag extra.Batch records have been reviewed; all required specification was met and documented within the batch records.All preventative maintenance was completed on this manufacturing line.Machine logs were reviewed and there were no issues reported relating to the complaint issue.(4) photographs were received and these confirm the dressings have disintegrated.A previous complaint issue was opened to investigate this issue which has now been completed and closed.It was noted that: ¿this appearance is not uncommon and it suggests that the wound was heavily exuding so that the hydrofiber gelled completely (as it¿s designed to do).The residue will most likely be on the dressing or the bandage (if no secondary dressing).From our perspective, there are no concerns but it would be good to confirm that the dressing met its specification.¿ a review of all process testing requirements within the batch history retention files identify that all are within the specification parameters.There were no discrepancies noted in the batch records related to the reported complaint issue.Therefore, this identifies that the product was manufactured per the quality system, validated processes and approved procedures in place at the time of manufacturing and packaging.This complaint issue is currently an isolated incident as no further like-for-like complaints have been received.This issue will be monitored through the post market product monitoring review process.No additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: AQUACEL AG EXTRA
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 6308849
• Report Number: 1000317571-2017-00007
• Device Sequence Number: 19122548
• Product Code: FRO
• UDI-Device Identifier: 00768455127375
• UDI-Public: 768455127375
• 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,o
• 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: 07/31/2021
• Device Model Number: 420676
• Device Catalogue Number: 420676
• Device Lot Number: 6F03578
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1