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

Model Number 108-E

Device Problem Disconnection (1171)

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

Event Date 02/11/2015

Event Type  malfunction  

Event Description

The complainant reports when attempting to fill the oxygen reservoir the oxygen tubing 'disconnected from the mask.' the complainant further reports the oxygen tubing disconnects easily 'with the hands.'.

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.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.This complaint involves three lots, therefore, a separate fda form 3500a will be submitted for each lot.

• Brand Name: 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 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4602818
• MDR Text Key: 5466361
• Report Number: 9680866-2015-00017
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 108-E
• Device Lot Number: 102785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2015
• Date Device Manufactured: 03/01/2014
• 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