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

Model Number	420678
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Skin Discoloration (2074); Tissue Damage (2104); Discharge (2225)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.No additional information has been received to date.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).
Event or Problem Description
It was reported that the end user started using aquacel ag extra to the right and left ischium pressure ulcers sometime in (b)(6) 2017.The dressing was changed daily by her husband or home health nurse.The peri-wound skin was cleaned with medline skintegrity wound cleanser.Aquacel ag extra was applied, then covered with gauze and secured with self-adhesive roll dressing.End user developed cellulitis (i.E., red, weepy, edematous skin) surrounding the wounds which then spread to entire body up to her mouth.It was reported that the end user experienced frothing at the mouth at this time and the wound bed developed eschar.A wound culture was taken and end user was started on prescription bactrim.The end user feels the cellulitis and other symptoms are a result of an allergic reaction to the aquacel ag extra however it is not known if the doctor provided the same diagnosis.It was also reported that the end user at first did not think the product was the cause of the allergic reaction but at the beginning of (b)(6) 2017 the aquacel ag extra was discontinued.It was noted that the end user returned to using the previous dressing dakins solution and the issue was resolved completely within 2 days.The skin is now fleshtone and not edematous or weepy and the wound bed is pink.The end user was advised to discontinue the use of aquacel ag extra.No further information has been provided.
Additional Manufacturer Narrative
Manufacturing date corrected from march 14, 2017 to march 13, 2017.Batch record has been reviewed.All required specifications were met and documented within the batch record.There were no discrepancies noted in the batch record.All sterilization results were received and satisfactory.Preventative maintenance was completed to schedule.Machine logs were reviewed and there were no issues relating to the complaint.This issue will be monitored through the post market product monitoring review process.No additional patient/event information has been received to date.Should additional information become available, a follow-up report will be submitted.(b)(4).
Additional Manufacturer Narrative
Correction to brand name from aquacel extra to aquacel ag extra.No additional patient/event information has been received 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: 6809906
• Report Number: 1000317571-2017-00043
• Device Sequence Number: 2066616
• Product Code: FRO
• UDI-Device Identifier: 00768455127450
• UDI-Public: 768455127450
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: K121275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 03/01/2020
• Device Model Number: 420678
• Device Catalogue Number: 420678
• Device Lot Number: 7C02545
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 12/14/2017; 01/08/2018
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 01/04/2018; 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR