MAUDE Adverse Event Report: CONVATEC LTD AQUACEL FOAM; DRESSING,WOUND,HYDROPHILIC

Model Number 420680

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tissue Breakdown (2681)

Event Date 08/26/2022

Event Type  malfunction  

Event Description

The nurse reported to the company's employee that she had to cease known company¿s dressing and company¿s another dressing evaluation on a diabetic patient who had foot plantar ulcer.The dressing was replaced, and the patient was scheduled for review on (b)(6) 2022.Furthermore, it was mentioned that the exudate was copious over three subsequent changes of dressing and that it did not manage this at all.It was stated that the exudate increased when they started using the first dressing and it appeared that the second dressing applied did not handle the increased exudate at all.The tissue integrity had deteriorated, and the peri wound was macerated.Medical attention was required, and new dressings had to be applied as per that.Peri wound maceration and exudate increased with each new dressing.The dressing was the only variance during this time.She felt that the patient had been compliant with her treatment.The duration of use was unknown.No photograph is available at this time.

Manufacturer Narrative

Device 2 of 3.Reporter information: (b)(6).(b)(4).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary: a batch record review was completed, and no discrepancies were found.Aquacel foam adh 10x10cm(1x10) nai was manufactured under system application product (sap) code (b)(4) and lot number 1k02072 manufactured on 22 nov 2021.Lot # 1k02072 was sterilized under order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 1k02072.This was the only complaint for the affected lot registered within database for aquacel not effective.No photographs were received for this complaint.Original samples were requested, but it was confirmed no samples were available, so could not be evaluated in accordance with work instruction (wi).It was therefore not possible to confirm the complaint.Retained samples were available for batch 1k02072, which were tested against the product specification for this product for fluid handling capacity.The laboratory results confirmed that fluid handling capacity for the dressings was within specification.As no nonconformity was identified, no nonconformance record was raised.It is confirmed that the dressings have met specification, so it is expected that the dressings will have been handling exudate as per the expectations and specification of the product.It is possible that exudate levels described in the complaint may have been higher than expected, but it is the responsibility of the healthcare professional to ensure wounds are dressed and monitored appropriately based upon the exudate levels experienced.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092, manufacturing site: 1000317571.

Event Description

To date no additional patient or event details have been received.

• Brand Name: AQUACEL FOAM
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15482745
• MDR Text Key: 302703882
• Report Number: 1000317571-2022-00323
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455127115
• UDI-Public: 00768455127115
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420680
• Device Catalogue Number: 420680
• Device Lot Number: 1K02072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1