MAUDE Adverse Event Report: UNOMEDICAL S.A DE C.V. ADUL MEDIUM CONCENTRATION MASK; MASK, OXYGEN

Model Number 1625-21

Device Problems Decoupling (1145); Fitting Problem (2183)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Date rec'd: 07/2020.Mfg date: 07/2015.Based on the available information, this event is deemed to be a reportable malfunction.No harm was reported.A return sample was not available for evaluation; therefore we could not confirm a discrepancy in the product.After a detailed batch record review, no discrepancies were found, the product was manufactured according to specification using the approved materials/ components.There is not enough information to conclude that the product did not meet specification and perform as intended, product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, this complaint will be closed.Additional patient/event information was requested, but not yet received.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the intermediate tubing connectors on the aerflo adult oxygen mask were very rigid.When the oxygen was turned on the tubing becomes loose and detaches from the mask.It is unknown if the device was used on a patient, no patient harm or further information was reported.

Manufacturer Narrative

This supplemental report is being submitted to update and correct additional codes that were erroneously omitted on the initial mdr submission dated (b)(6) 2016.(b)(4) was submitted in error as the batch review did not find any discrepancies during the manufacturing process.Corrected data: brand name: adult medium concentration mask.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.A return sample for evaluation is not expected.

• Brand Name: ADUL MEDIUM CONCENTRATION MASK
• Type of Device: MASK, OXYGEN
• 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: 5446121
• MDR Text Key: 38538994
• Report Number: 9680866-2016-00064
• Device Sequence Number: 1
• Product Code: BYG
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1625-21
• Device Lot Number: 113182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2016
• 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