MAUDE Adverse Event Report: CONVATEC INC AQUACEL FOAM; DRESSING,WOUND,HYDROPHILIC

Model Number 420636

Device Problem Nonstandard Device (1420)

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Additional patient/event details have been requested but not provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported the "aquacel inside of foam cannot absorb exudate properly".The dressing was reported to be changed every third day which end user alleges led primarily to maceration as well as necrosis that occurred on a small wound area.The treating physician noticed a change in the wound but, was unable to confirm when the change occurred.The patient did not have any serious problems that required medical treatment other than debridement of the affected area.Per the information provided, the end user has multiple wounds with multiple dressings used from multiple lots.The total amount of dressings related to the maceration and necrosis is still unknown.Photographs of the product were provided.

• Brand Name: AQUACEL FOAM
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american avenue; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 8637532
• MDR Text Key: 145976255
• Report Number: 1049092-2019-00197
• 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,health pr
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2023
• Device Model Number: 420636
• Device Lot Number: 2705807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• 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