MAUDE Adverse Event Report: CONVATEC INC AVELLE; POWERED SUCTION PUMP

Model Number 421552

Device Problems Connection Problem (2900); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported the patient had an avelle dressing applied on the foot, "and for three times the connector was ¿unhook¿ from the dressing tube." a photograph depicting the reported complaint issue was provided by the complainant.

Manufacturer Narrative

(b)(6).A query was run on 02dec2019 against lot number wo022791 for malfunction code wnd-pmc1.8 port on avelle dressing (i.E that connects dressing to airway tube) detaches or delaminates from dressing layers (avelle only), which yielded 1 occurrence(s).A detailed investigation or batch record review is not required as the severity rating is low and the occurrences of complaints with this unique malfunction code - batch combination does not meet the limit criteria per our procedure.A photo/video was received with this complaint should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 1049092.Third party manufacturing site: 3007648359.

Event Description

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

• Brand Name: AVELLE
• Type of Device: POWERED SUCTION PUMP
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 8859534
• MDR Text Key: 153228500
• Report Number: 1049092-2019-00212
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K180205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: 421552
• Device Lot Number: WO022791
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1