MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OPTI-MIST PLUS NEBULIZER WITH AEROSOL MASK KIT; NEBULIZER (DIRECT PATIENT INTERFACE), 73CAF

Model Number 3773MM

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/16/2014

Event Type  malfunction  

Event Description

It is reported the product was taking too long for medication to become a mist and was difficult to breathe in by the pt "one (1) day".

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of a pt being harmed as a result of this malfunction.The distributor, terumo fisher scientific requested the product and will return to the manufacturer for investigation.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.

• Brand Name: OPTI-MIST PLUS NEBULIZER WITH AEROSOL MASK KIT
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE), 73CAF
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon; lote 7, parque ind. del norte; reynosa, tamaulipas 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, associate dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4098404
• MDR Text Key: 4717295
• Report Number: 9680866-2014-00024
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: 3773MM
• Device Catalogue Number: 3773MM
• Device Lot Number: 98778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention