MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ® FIRST BREATH ADULT TRACHEOSTOMY MASK; MASK, OXYGEN, NON-REBREATHING

Catalog Number 001305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Tissue Damage (2104); Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

Event Description

It was reported that the patient experienced pressure wounds from the tracheostomy mask since the product material has changed to a more solid material.It is unknown whether the event has been resolved, however, it was reported that the patient was changed to a competitor's brand.No further adverse health outcomes have been reported.See mfr: 3012307300-2016-00593.

• Brand Name: PORTEX ® FIRST BREATH ADULT TRACHEOSTOMY MASK
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 9124 polk lane; suite 101; olive branch MS 38654
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6201007
• MDR Text Key: 63194288
• Report Number: 3012307300-2016-00595
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 001305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2016
• 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