MAUDE Adverse Event Report: UNOMEDICAL SA DE CV OPTI-MIST CLEAR NEBULIZER, KIT; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 86-775-E

Device Problems Defective Device (2588); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2011

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 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complaintant reports "end user used this item and several nurses have complained about that this lot#, did not deliver medication correctly.".

• Brand Name: OPTI-MIST CLEAR NEBULIZER, KIT
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 5208026
• MDR Text Key: 30636809
• Report Number: 9680866-2015-31236
• Device Sequence Number: 1
• Product Code: CAF
• 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: consumer,health professional
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 86-775-E
• Device Lot Number: 11-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention