MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187955

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516); Tissue Breakdown (2681)

Event Type  malfunction  

Event Description

End user¿s daughter who is also the care provider reported that they had been using this product for many weeks and that it was prescribed by the consumer's doctor of medicine (md).She purchased it from a local pharmacy with a prescription.The prescription stated to change the product every three days.She uses two 4x4 dressings with each change to cover the wounds.She stated that the wounds had been healing with use of the product and that it usually was very easy to remove on the third day.The complaint product was from a new market unit.She stated that when she went to remove the dressing, it appeared like it was glued to her skin and she had great difficulty removing it.The force of the removal caused skin tearing.She stated that the skin started to bleed due to the skin tearing.She cleaned the wound and skin tore and she applied two new dressings from the same market unit.The complainant reported that the same thing happened that day and she was not able to remove the dressings due to them being adhered like glue to the skin.Hence, a total of four dressings were used.The product was used on patient.No photo is available at this time.

Manufacturer Narrative

Device 3 of 4.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.(b)(4).

• Brand Name: L3W0750 - DUODERM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• 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: 14039704
• MDR Text Key: 288794266
• Report Number: 9618003-2022-00465
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187955
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• 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
• Patient Age: 87
• Patient Sex: Female