MAUDE Adverse Event Report: MASIMO CORPORATION LNCS NEO-L ADHESIVE SENSOR

Model Number 1862-1

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Peeling (1999)

Event Date 07/31/2014

Event Type  Other  

Event Description

It was reported that redness of the skin a plantar part of right foot was observed at sensor applied area.Skin peeling at the dorsum of right foot was observed at sensor applied area.The health care worker found the symptom about 5 hours after the site change.She checked and changed the applied site every 4-5 hours.3m microfoam medical tape was wrapped over the sensor.Additional information received (b)(4) 2014: the affected area has resolved on its own without any medication and the patient is doing fine.

Manufacturer Narrative

The device has been returned to masimo for evaluation.When the investigation is complete, a follow up report will be submitted.

• Brand Name: LNCS NEO-L ADHESIVE SENSOR
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.; calzada del oro no. 2001; paque industrial palaco
• Manufacturer Contact: jodi swindle ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4066346
• MDR Text Key: 20012611
• Report Number: 2031172-2014-00152
• Device Sequence Number: 1
• Product Code: DQA
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1862-1
• Device Catalogue Number: 1862-1
• Device Lot Number: 14AUK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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
• Treatment: 3M MICROFOAM MEDICAL TAPE
• Patient Outcome(s): Other
• Patient Weight: 2