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

Model Number 86-777-E

Device Problem Improper Flow or Infusion (2954)

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

Event Date 07/18/2014

Event Type  malfunction  

Event Description

It was reported that some of the masks in the case have little or no mist.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.It is unknown if the device was used by any end user(s), however, it was stated that no medical treatment was given and the end user(s) did not incur any serious injuries.It was also stated the end user(s) are now using a competitors brand with no problems.Additional information was requested regarding the flow rate of the device, however no additional information has been received to date.No additional patient/event details have been provided, should additional information become available a follow up report will be submitted.Reported to the fda on (b)(4) 2014.

• 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, associate dir. ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4062786
• MDR Text Key: 4897439
• Report Number: 9680866-2014-00021
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/29/2014

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: 01/01/2014
• Device Model Number: 86-777-E
• Device Catalogue Number: 86-777-E
• Device Lot Number: 101450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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