MAUDE Adverse Event Report: CONVATEC INC. AQUACEL AG SURGICAL HYDROFIBER DRESSING; DRESSING, WOUND, DRUG

Model Number 412010

Device Problems Failure To Adhere Or Bond (1031); Device Handling Problem (3265)

Patient Problems Skin Irritation (2076); Fluid Discharge (2686)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction, the product indicated was used longer than seven (7) days.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).Note: a total of two cases are associated with this complaint.A separate fda form 3500a has been completed for the unknown amount of dressings associated with this complaint.

Event Description

It was reported by a nurse that a dressing being used on the chest wall after the implantation of a cardiac device was not adhering on all sides.It is not known when the dressing lifts initially, although it was discovered that the dressing was being left in place for more than 7 days until the patient returned for the follow up appointment that occurred some weeks after the application of the dressing.It was the opinion of one of the physician's on staff that the lifting of the dressing could be causing the surgical site from the implants in the chest wall to become infected as he is noting redness and drainage at the surgical site; no patient information was available.He additionally stated that they did not have this problem prior to using the surgical dressing as they had their patients wrap the area with saran wrap when showering.

• Brand Name: AQUACEL AG SURGICAL HYDROFIBER DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5414478
• MDR Text Key: 37618856
• Report Number: 1049092-2016-00040
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2016

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
• Device Operator: Health Professional
• Device Model Number: 412010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1