MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN & AEROSOL THERAPY; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 3773MM

Device Problem Improper Flow or Infusion (2954)

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

Event Date 06/26/2014

Event Type  malfunction  

Event Description

It was reported the device was taking over twenty minutes to load and there was "not a good mist coming through.".

Manufacturer Narrative

Based on the available information this event is deemed a reportable malfunction.Additional patient/event information was requested on (b)(4) 2014, however no further information has been received to date.The complaint sample is not expected to be available for evaluation.This complaint is being evaluated.There are no previous complaints for this product.No previous investigation exists for this issue for this product.Based on this review, unable to determine if product meets specification.An investigation is required to determine if any further actions are required.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: OXYGEN & AEROSOL THERAPY
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa, tams. 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3979525
• MDR Text Key: 21727572
• Report Number: 9680866-2014-00020
• 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,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/26/2014

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2019
• Device Model Number: 3773MM
• Device Catalogue Number: PMD02603
• Device Lot Number: 101556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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