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

Model Number 420680

Device Problem Material Disintegration (1177)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Complainant was unable to provide the lot number or product sizing information.Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.Although a photograph has been received, no evaluation will be conducted.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.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.(b)(4).

Event Description

It was reported the ¿aquacel wound contact layer found to have disintegrated into small granules into the patient's leg wound with the inner layer of the dressing detached from the dressing and stuck and the granules embedded into the wound." upon removal of the dressing some bleeding occurred.It was reported that the dressing was worn for three days.The wound was cleaned and a new aquacel foam dressing was applied.Photos depicting the reported complaint issue were provided by the complainant.No further information was 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 ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 8014516
• MDR Text Key: 125450885
• Report Number: 1049092-2018-00523
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Model Number: 420680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/29/2018
• 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
• Patient Age: 80