MAUDE Adverse Event Report: CONVATEC INC

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

Based on the available information, this event is deemed to be a reportable malfunction.Additional information has been requested, however to date no additional information has been received.The lot number was not provided.  therefore, we are unable to determine the specific manufacturing site. should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported the dressing was difficult to remove after being in place 3-5 days post operation for a total hip arthroplasty (exact location unknown).The dressing was removed using alcohol and gauze.It was further reported that the adhesive felt stronger and more aggressive resulting in pain for the patient.The patient¿s incision is closed with staples and no injections or surgical glues were used prior to closure of the surgical wound.They informed that the dressing is not warmed prior to application, nor is it stretched or applied under tension.No harm was reported.

Manufacturer Narrative

Aquacel/ aquacel ag surgical cover dressing.Dressing, wound, hydrophilic.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.No additional information has been received to date.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).

Event Description

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

• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 8320076
• MDR Text Key: 135519477
• Report Number: 1049092-2019-00134
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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?: Yes
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1