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

Model Number 108MM

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.No patient information was provided due to (b)(6) privacy laws.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on: july 01, 2016.(b)(4).Note: a total of two cases are associated with this complaint.A separate fda form 3500a has been completed for that case.

Event Description

Complaint received from a distributor reporting that "the tube break off from the mask.This occurs the oxygen desaturation for the patient." photos were received depicting the reported product complaint.

Manufacturer Narrative

Expiration date (08/2019).The used product sample received was disposed of and no evaluation could be performed due to contamination upon receipt.Should additional information become available, a follow-up report will be submitted.No additional patient/event details have been provided to date.However, this issue will be monitored through the post market product monitoring review process.(b)(4).

Manufacturer Narrative

A preliminary evaluation of the reported cases were reviewed collectively due to similar failure modes reported for tubing disconnecting from mask.These complaints included a review of complaints reported between october 27, 2014 to october 27, 2016 (2 year period) for this failure.Additionally, the last product monitoring reviews (pmrs) were also reviewed and no trends were identified.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 december 27, 2016.

Manufacturer Narrative

This supplemental report is being submitted to correct the mfr report# for follow-up report#01 to 9680866-2016-00076, which was transcribed incorrectly during submission on january 05, 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 as it relates to reported malfunction for the oxygen therapy product, (108mm).A total of eight (8) complaints were reported.However, there was one (1) non-conformance opened to investigate reports of tubing disconnecting from the oxygen therapy masks from various lot numbers.The non-conformance identified possible root causes as: inadequate assembly work instructions, and inadequate solvent dispenser.Corrective actions were implemented.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.Fda registration number: reporting site: (b)(6).Manufacturing site: (b)(4).

• Brand Name: NON-REBREATHER OXYGEN 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 Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5766103
• MDR Text Key: 48714539
• Report Number: 9680866-2016-00076
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2016

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: 108MM
• Device Lot Number: 105987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/13/2016; 12/27/2016; 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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