MAUDE Adverse Event Report: UNOMEDICAL SA DE CV ADULT OXYGEN MASK WITH TUBING,02 DILUTER JETS (6),OXYGEN TUBE, NEBULIZER HOOD; MASK, OXYGEN, LOW CONCENTRATION, VENTURI

Model Number I002610

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2014

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21 cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Customer reported that the whistle sound was heard from the connection between the oxygen and the flowmeter, so the device was changed to the new one.

• Brand Name: ADULT OXYGEN MASK WITH TUBING,02 DILUTER JETS (6),OXYGEN TUBE, NEBULIZER HOOD
• Type of Device: MASK, OXYGEN, LOW CONCENTRATION, VENTURI
• Manufacturer (Section D): UNOMEDICAL SA DE CV; av. industrial falcon lote 7; parque ind del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5204466
• MDR Text Key: 30722401
• Report Number: 9680866-2015-31375
• Device Sequence Number: 1
• Product Code: BYF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: I002610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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