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

Model Number 403772

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 2.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Preventive maintenance (pm) logs have been checked and all pm's were completed with no discrepancies.Affected amount: 2 pieces (pcs).Aquacel wsf 2.5x45cm was manufactured under system application product (sap) code (b)(4) and manufacturing lot number 0b01633.Lot number 0b01633 was sterilized under lot 1240104111 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 were run in accordance with process instructions (pi) for machine doyen 1.A visual inspection was performed in accordance with testing method (tm) and completed at the beginning of the order and every hour following until the order was completed.No nonconformity was registered during the manufacturing process of lot 0b01633.This is the only complaint for the affected lot registered within complaint handling system.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 ¿that the patient returning two dressing in which they found hair inside the blister." the product was not used, and no photographs were provided.

• 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
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10488631
• MDR Text Key: 205670632
• Report Number: 1000317571-2020-00039
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 403772
• Device Lot Number: 0D01633
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1