MAUDE Adverse Event Report: CONVATEC INC AVELLE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	421553
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1: complainant city: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Should additional information become available, a follow up report will be submitted.Fda registration number reporting site: 1049092 third party manufacturing site: 3007648359.
Event or Problem Description
It was reported "the dressing is not functioning properly.The pump is checked and is working properly.The length of the dressing port is checked and its rupture is evident.".
Additional Manufacturer Narrative
Investigation findings: no prior non-conformances for this batch.Batch record and test results were within specification.No changes in environment, materials, methods, personnel, or equipment.Ishikawa diagram used to assess potential causes¿no concerns identified.Supplier not deemed responsible.No risk to other batches or similar items.Root cause: undetermined due to lack of returned product.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092, third party manufacturing site: 3007648359.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: AVELLE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 23309366
• Report Number: 1049092-2025-00232
• Device Sequence Number: 5135142
• Product Code: OMP
• UDI-Device Identifier: 00768455139262
• UDI-Public: 00768455139262
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K180205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 421553
• Device Lot Number: WO036204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown