MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL SURGICAL; DRESSING,WOUND,HYDROPHILIC

Model Number 420669

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that it was difficult to remove the dressing.The product was used on patient.There was no harm reported.A video associated with the issue was received from the complainant.

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 9618003.

• Brand Name: AQUACEL SURGICAL
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18383680
• MDR Text Key: 331217385
• Report Number: 9618003-2023-15332
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420669
• Device Lot Number: 3B01005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1