MAUDE Adverse Event Report: CONVATEC LTD; DRESSING, WOUND, HYDROPHILIC

Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Brand name: aquacel/aquacel ag - surgical cover dressings.Based on the available information, this event is deemed to be a reportable malfunction.Additional information was requested, but the complainant was only able to provide this information.Complainant was unable to provide the model number, lot number or product sizing information.No lot number is available.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 an aquacel ag surgical dressing was difficult to remove from a patient requiring hip surgery.The dressing was applied after surgery and removed by home health on the seventh day.It is unknown if any products were used on the skin before application of the dressing or during removal.The patients¿ dressing was replaced with a new aquacel ag dressing.It is unknown if there was untoward affect to the patient.It was further reported that the convatec territory manager has provided instruction to the center on how to remove the dressing and he will continue to educate staff in same.

• 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: 8731851
• MDR Text Key: 149109209
• Report Number: 1000317571-2019-00074
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WOUND CARE-UNKNOWN SURGICAL COVER DRESSI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2019
• 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