MAUDE Adverse Event Report: UNOMEDICAL SA DE CV OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT; MASK, OXYGEN, NON-REBREATHING

Model Number 86-108E 543538

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Complaint reporting "mask does not allow patient to breathe correctly.It is cutting off air with deep breaths." no further information was provided.

Manufacturer Narrative

This supplemental report is being submitted to correct the mfr report# for follow-up report#01 to 9680866-2016-00092, which was transcribed incorrectly during submission on january 19, 2017 in error.The last three (3) product monitoring reviews (pmrs) were reviewed and none of the affected product codes have illustrated any trends for product category or any malfunction or any harms.More specifically, there were no trends observed for the oxygen masks.Complaints spanning october 27, 2014 to october 27, 2016 (2 years) were reviewed as it related to reports of poor performance and cutting off oxygen flow, total of one (1) complaint was reported.No trends were observed and no harms reported.In all cases, the product was discontinued and replaced.This issue will be monitored through the 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.Reported to the fda on march 21, 2017.(b)(4).

• Brand Name: OXYGEN MASKS, ELONGATED (UNDER CHIN), ADULT
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL SA DE CV; 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5201145
• MDR Text Key: 70371535
• Report Number: 9680866-2016-00092
• Device Sequence Number: 1
• Product Code: KGB
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

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: 86-108E 543538
• Device Lot Number: 052616N02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• 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