MAUDE Adverse Event Report: MMJ SA DE CV (USD) NELLCOR; OXIMETER

Model Number	MAXNJ
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during use, a red inflammation-like substance was observed on the dorsum of the foot, where the sensor was applied.The patient's family reported that the product was removed within eight hours and confirmed that there was no major difference from the instructions on the package regarding the position of application.It was suspected for burn and bedsore, but the patient had no medical consultation by the attending physician, so there was no medical prescription at this time.After a medical professional was consulted and the position of application from the instep to the thumb was changed, there were no problems.The product was continued to use while monitoring the patient's condition.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19521022
• Report Number: 2936999-2024-00897
• Device Sequence Number: 8337315
• Product Code: DQA
• UDI-Device Identifier: 20884522041710
• UDI-Public: 20884522041710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAXNJ
• Device Catalogue Number: MAXNJ
• Device Lot Number: 233250052H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/12/2024
• Date Device Manufactured: 11/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown