MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC GRANUFLEX; NOT APPLICABLE

Model Number 187954

Device Problems Material Disintegration (1177); Difficult to Remove (1528)

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

Event Type  malfunction  

Event Description

It was reported that dressing was much more difficult to remove from skin when changing dressings than it used to be.The dressing got stuck extremely strongly, sometimes only be removed in pieces for which more use of adhesive remover required significantly.Along with the company's dressing, the treatment regimen of the practitioners provided for the additional use of a foil bandage to minimize the rolling up of the bandage edges of dressing so far with complete satisfaction.Although the products were heavier and more time-consuming to use, the customer continued to use the products before and after reporting the detected quality change as they saw no risk to the patients.According to the customer, he reported this issue for several uses and due to the accumulation of difficult handling of the product.The difficulty in detaching from the skin was independent of the skin type.The product was used for two to four days.There was no harm reported.The photographs depicting the issues were received from the complainant.

Manufacturer Narrative

Device 13 of 22.Common device name ¿ dressing, wound, occlusive.Complainant city: (b)(6).Complainant state: (b)(6).Complainant postal code: (b)(6).Complainant country: austria.Name of affiliation: rehazentrum felbring.As per the information provided by complainant, for the issue dressing too sticky, the imdrf med.Dev.Prob.Code (b)(4).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:(b)(4).Manufacturing site: (b)(4).

Event Description

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

• Brand Name: GRANUFLEX
• Type of Device: NOT APPLICABLE
• 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: 15561259
• MDR Text Key: 306793873
• Report Number: 9618003-2022-05125
• Device Sequence Number: 1
• Product Code: NAD
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 187954
• Device Lot Number: 2A03104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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