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

This emdr is being submitted for issue experienced on unknown number of patients.The product field manager visited a center, where elderly people went after a surgery to recover.Patients with total knee arthroplasty (tka) and total hip arthroplasty (tha) come from hospital with company¿s surgical dressing applied.It was reported by the nurse that it was difficult to remove the dressings since they were really sticky and when they achieve to remove the dressing there are a lot of ¿hydrocolloid ¿ debris¿ so they have to clean the skin aggressively.Dressings are usually in place between six and ten days.The product was used on patient.There was no harm or reaction reported.No photo is available at this time.

Manufacturer Narrative

E1: complainant street address: (b)(6).Complainant city: (b)(6).Complainant state: (b)(6).Complainant postal code: (b)(6).Complainant phone: (b)(6).Complainant country: (b)(6).Name of affiliation: (b)(6).Name of hospital : (b)(6).H6: medical device problem code: as per the information provided by complainant, for the issue dressing really sticky, the imdrf med.Dev.Prob.Code a050901 (adhesive too strong) is not available for selection.Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.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.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: 18138396
• MDR Text Key: 328241323
• Report Number: 9618003-2023-11548
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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