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

Model Number 420676

Device Problems Material Disintegration (1177); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2017

Event Type  malfunction  

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 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.

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
• Type of Device: DRESSING, WOUND, DRUG
• MDR Report Key: 6308849
• MDR Text Key: 66771662
• Report Number: 1000317571-2017-00007
• Device Sequence Number: 1
• Product Code: FRO
• UDI-Device Identifier: 00768455127375
• UDI-Public: 768455127375
• Combination Product (y/n): N
• PMA/PMN Number: K121275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1