MAUDE Adverse Event Report: O2 SENSOR

Lot Number 502762A

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Hypersensitivity/Allergic reaction (1907); Misdiagnosis (2159)

Event Date 03/22/2016

Event Type  Injury  

Event Description

He was misdiagnosed with copd.Combivent,ipratropium bromide, put in the hospital, had allergic reaction.Also o2 sensor caused him not to get enough oxygen to lungs and heart, they're killing him.It's all a fraud.Dose or amt: 2x, frequency: twice daily, route: inhalation.Diagnosis or reason for use: supposedly copd.Event abated after use stopped or dose reduced: no.Event reappeared after reintroduction: yes.

• Brand Name: O2 SENSOR
• Type of Device: O2 SENSOR
• MDR Report Key: 5525726
• MDR Text Key: 41252192
• Report Number: MW5061253
• Device Sequence Number: 1
• Product Code: CCL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2016
• Device Lot Number: 502762A
• Other Device ID Number: 7133103
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Weight: 135