MAUDE Adverse Event Report: CONVATEC LTD L3W0650 - AQUACEL FOAM; DRESSING, WOUND, DRUG

Model Number	421580
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by company representative that the woc (wound, ostomy, and continence) nurse told him that five dressings from one market unit were not as absorptive as the other company's dressing and left the wound with areas of maceration.They had been trialing the product as a replacement for other company¿s foam dressing.Three attempts have been made and one electronic mail (email) was sent requesting further information to contact the woc (wound, ostomy, and continence) nurse but it was not possible to contact her.No additional information is available at this time.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Device 4 of 5.Role of complainant : regional clinical specialist.Name of hospital : (b)(6).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).
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: d9: device available for eval & date returned to mfg h3: device evaluated by mfg 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 pro sacral 24x21.5cm 1x5 nai was manufactured under system application product (sap) code (b)(4) and manufacturing lot number 1k01013 on 11/10/2021.Lot # 1k01013 was sterilized under reference (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 1k01013.There are 2 complaints for this affected lot number in database - this complaint for maceration and the additional complaint noted above for the dressing leaving residue in the wound.One photograph was received for this issue and has been evaluated in accordance with work instruction.The photograph confirms the expected lot number and product but does not show the complaint issue.The samples under complaint were requested for investigation as part of complaint records, received on 29/06/2022.A non-conformance was open for this complaint raised as a result of the related complaints relating to silicone residue.The original complaint states that the dressings were being trailed as a potential replacement for ¿mepilex¿ (competitor¿s foam dressings), and that the nurse felt the dressings were not absorptive as the competitor¿s product and that the wound was left with areas of maceration.The sample dressings received were tested for fluid uptake as per product specification for aquacel foam pro dressings.The fluid uptake results for the dressing from lot 1k01013 was found to be within specification, so the maceration noted by the complainant may indicate that the dressing size was not suitable for the exudate levels released by the wound.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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.

• Brand Name: L3W0650 - AQUACEL FOAM
• Common Device Name: DRESSING, WOUND, DRUG
• 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: 15011380
• Report Number: 1000317571-2022-00112
• Device Sequence Number: 2517303
• Product Code: NAC
• UDI-Device Identifier: 00768455140503
• UDI-Public: 00768455140503
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• Device Model Number: 421580
• Device Catalogue Number: 421580
• Device Lot Number: 1K01013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male