MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CANNULA, ADULT, OXYGEN W/3-CHANNEL TUBE 7'

Model Number 1600-7-50

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

The patient developed lesions from the device and allergic reactions.

Event Description

When his oxygen was installed, he was provided with glasses which caused him an allergy, with itchy eczema-like lesions at the level of the tubing (under the chin, and in the neck).No change in cosmetic product habits that could explain an allergy.No misuse of the glasses.The patient saw the lesions disappear as soon as she changed her glasses model. .

Event Description

When his oxygen was installed, he was provided with glasses which caused him an allergy, with itchy eczema-like lesions at the level of the tubing (under the chin, and in the neck).No change in cosmetic product habits that could explain an allergy.No misuse of the glasses.The patient saw the lesions disappear as soon as she changed her glasses model. .

Manufacturer Narrative

The patient developed lesions from the device and allergic reactions.There have been 2 similar complaints in the previous 24 months for 1600 series cannula under "skin irritation/reaction".No returned material, no pictures of defect/skin reaction.Complaint cannot be confirmed.Root cause: skin sensitization is a well-known risk and occurs most often when patients are first exposed to cannula or when using the cannula for a prolonged period of time.Cannulas may harden over time and cause irritation, that is why it is recommended to change cannula out every 14 days.Sensitivity to the pressure of the tubing can increase over time and can be mitigated by switching from 1600 to a 16soft style cannula or using products such as ez-wraps.Risk(rma-20017a): r1: patient skin contact with cannula - patient exposed to cannula repeatedly over long-term use - s=7 o=2 rpn=14.Rpn < 25, therefore risk is acceptable.

• Brand Name: SALTER LABS
• Type of Device: CANNULA, ADULT, OXYGEN W/3-CHANNEL TUBE 7'
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17978299
• MDR Text Key: 326185796
• Report Number: 3000219639-2023-00028
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 00607411100253
• UDI-Public: 00607411100253
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1600-7-50
• Device Catalogue Number: 1600-7-50
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other