MAUDE Adverse Event Report: CONVATEC LTD AQUACEL/AQUACEL AG - EXUDATE MANAGEMENT HYDROFIBER DRESSING ROPE; DRESSING,WOUND,HYDROPHILIC

Model Number 403770

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device 3 of 3.(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.(b)(4).

Event Description

It was reported the sealed edge of the packaging was sealed onto the product.The product was not used.Photos depicting the reported complaint issue were provided by the complainant.

Event Description

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

Manufacturer Narrative

G.2: correcting distributor to user facility.E.1: affiliation - (b)(6) hospital.A batch record review indicates no discrepancies.Preventive maintenance (pm) logs have been checked and all pm's have been completed.Affected amount: 3pcs.Aquacel wsf 2x45cm was manufactured under system application products (sap) code (b)(4) and manufacturing lot number 9c00983.Lot number 9c00983 was sterilized under lot 1224974111 and released on review of results of sterilization.All the results were within specification and products were released.The production process, in process testing and packaging of products was run in accordance with process instructions for machine (b)(4) one (1).A visual inspection was performed in accordance with testing methods and completed at the beginning of the order and every fifteen (15) minutes following until the order was completed.No nonconformity was raised during the manufacturing process of lot 9c00983.This is the only complaint for the affected lot registered within complaint handling system.A photograph has been received and has been evaluated in accordance with work instructions.The photograph confirms the complaint issue, that this is a convatec product and the lot number.A root cause investigation was created for seal breaches.It was decided that the investigation would no longer be needed, and a complaint investigation project would be completed outside of trackwise to address all the seal issues on all (b)(4) machines including dressing in seal along with this complaint, are within the scope of the project.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.

• Brand Name: AQUACEL/AQUACEL AG - EXUDATE MANAGEMENT HYDROFIBER DRESSING ROPE
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• MDR Report Key: 9492007
• MDR Text Key: 200432041
• Report Number: 1000317571-2019-00119
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2024
• Device Model Number: 403770
• Device Lot Number: 9C00983
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1