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

Model Number 420127

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

(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 that aquacel rope 1 x 45cm was used on a patient that ¿suffers from a fistulae due to bowel cancer.When the patient was released from the hospital two weeks ago the wound expert of the doctor´s office continued the treatment as done in hospital by tamponading the fistulae with the aquacel rope.Upon changing the rope today several rope fragments of greenish color smeared with fester came out of one fistula.It was not determined how long these have been in the body.¿ no harm or complications reported in this connection.A photograph was provided by the complainant.

Manufacturer Narrative

A batch record review indicates no discrepancies.Machine logs have been checked and no issues were found.Preventive maintenance (pm) logs were checked and pm's were completed.Lot number 7e02684 was sterilized and released on review of results.All the results were within specification and the products were released.The production process, in process testing and packaging of products was run in accordance with process instructions for machine universal.Visual inspection performed in accordance with testing method was completed at the beginning of the order and every fifteen minutes following until the order was completed.No nonconformity was raised during the manufacturing process of lot 7e02684.This is the only complaint for the affected lot registered within trackwise 8.7.A photograph has been received to be evaluated in accordance with work instructions.The photograph shows fragments of the dressing that have been removed from a wound.The photograph does not confirm the lot number or the product.Testing results were reviewed for the whole process of the manufacturing of the lot for tensile testing in accordance with testing methods and fluid uptake testing in accordance with testing methods.The results for the tensile testing and the fluid uptake testing were both well above the minimum specification.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.

Event Description

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

• 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: 8848004
• MDR Text Key: 162025556
• Report Number: 1000317571-2019-00090
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: 420127
• Device Lot Number: 7E02684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1