MAUDE Adverse Event Report: CONVATEC LTD L3W0650 - AQUACEL FOAM

Model Number 422358

Device Problems Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Tissue Breakdown (2681)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

The sales representative raised the issue reported by tissue viability nurse (tvn) in leg ulcer clinic via electronic mail (email) that the end user had an adverse reaction and the trial was stopped with him on monday (fourteenth of march).It was reported that there was increase in exudate, redness, tissue damage and maceration of chronic wound with regression malodor due to which the trial was stopped.It was also reported that the exudate had strike through to the outer layer of the bandage and there was malodor reported.The dressing was completely saturated as well as the bandages and skin was completely macerated.Patient was previously treated on twenty eighth of february with other company's antimicrobial barrier protection bandages as well as another company's dressings.The duration of use was four days.On third of march, end user was re-dopplered and everything was fine and another company's antimicrobial barrier protection bandages were applied.On seventh of march end user was re-dopplered and applied company's dressing.On tenth of march, skin was macerated and odor was observed.It was washed in wound irrigation solution and anti-biotic topical cream and company's dressing was applied.On fourteenth of march, the evaluation was stopped.No photograph is available at this time.

Manufacturer Narrative

The report submitted on 04/14/2022, patient identifier (b)(6) had the incorrect manufacturer report number listed (mdr 9618003-2022-00475).The correct manufacturer report number should be mdr with patient identifier (b)(6) which has been submitted as of (b)(6) 2022.(b)(4).End user gender has been selected as male on the basis of information given in describe event of problem.Common device name: dressing,wound,hydrophilic.Product code: nac.Complainant city: (b)(6).Complainant country: (b)(6).Name of hospital: (b)(6).Pma /510(k) #: exempt.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.Fda registration number reporting site: (b)(4).Manufacturing site: (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.Batch record review results: a batch record review was completed for the affected batch and no discrepancies were found.All in-process tests have been carried out satisfactorily.Aq foam pro 15x15cm 1x10pk ster eur was manufactured under sap code 1727478 and manufacturing lot number 1m00295 on 15 dec 2021.Lot # 1m00295 was sterilised under order (b)(4) and released on review of results of sterilisation provided by sterilisation company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 1m00295.This was the only complaint for the affected lot registered within database.No photographs were received for this issue, so it was not possible to evaluate according to work instruction.As there were no images, it was not possible to confirm the complaint.As the complaint could not be confirmed, no nonconformance was raised and no investigation was raised.No further investigation into this complaint issue was possible.This issue will be monitored through the post market product monitoring review process.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: L3W0650 - AQUACEL FOAM
• 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: 14314604
• MDR Text Key: 295874507
• Report Number: 1000317571-2022-00073
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455157334
• UDI-Public: 00768455157334
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 422358
• Device Lot Number: 1M00295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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
• Patient Sex: Male