MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. AERFLO 3 IN 1 MASK - ADULT; MASK, OXYGEN, NON-REBREATHING

Model Number 1635-10

Device Problem Disconnection (1171)

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

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that while attempting to remove the distal female tubing connector in order to connect the nebulizer, the entire hard tube came away from the mask.It was also reported that when the nebulizer is then inserted (into the mask) and the oxygen is turned on, the nebulizer is blown off of the mask continuously.This reportedly occurred more frequently in cold weather conditions.There was no patient harm reported as a result of the product issue.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Note: there are seven (7) cases associated with this product; therefore a separate fda form 3500a has been generated to address the other six (6) cases.

Manufacturer Narrative

Additional information received: samples are not being returned and the record is being updated to reflect this information.Since lot number or product evaluation sample isn't available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: AERFLO 3 IN 1 MASK - ADULT
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon lote 7; parque ind. del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4951722
• MDR Text Key: 6195729
• Report Number: 9680866-2015-00061
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2015

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: Health Professional
• Device Model Number: 1635-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/28/2015
• 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: Initial
• Patient Sequence Number: 1