RESPIRONICS VITAL SENSE CAPSULE SENSOR 500-0100-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-13 for RESPIRONICS VITAL SENSE CAPSULE SENSOR 500-0100-02 manufactured by .

Event Text Entries

[21048646] Research participant ingested a vitalsense capsule sensor, core temperature capsule, manufactured by respironics at 0845. Participant stated that capsule became "stuck" on left upper lip before swallowing with water. Consumed breakfast and routine home medications (lisinopril/hctz) at 1000. Noticed left upper lip tingling 30 minute later. Waited to report to staff until approx 1330 of left upper lip tingling and swelling. Reported one episode similar in past as reaction to iodine. Upon exam noted slight left upper lip edema. Denied add'l signs or symptoms. Participant given diphenhydramine 25 mg po. Localized lip swelling progressed to entire left lateral lip, without add'l signs and symptoms. Participant given 2nd dose of diphenhydramine 25 mg po. Lip edema progressed over next 2 hours and referred to er for further eval and treatment. Treated with iv decadron, iv famotidine and diphenhydramine in the er, and admitted for observation (< 23 hour stay). Was given iv fluids of normal saline for hydration. Hospital stay without complications. Hospital discharge diagnosis: angioedema likely due to ace inhibitors. Lisinopril discontinued. Discharged home on hydrochlorthiazide for hypertension management. Research coordinator followed up with participant on (b)(6) 2013 via phone with reported complete resolution of signs and symptoms.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5029371
• MDR Report Key: 3010681
• Date Received: 2013-03-13
• Date of Report: 2013-02-28
• Date of Event: 2013-01-22
• Date Added to Maude: 2013-03-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RESPIRONICS VITAL SENSE CAPSULE SENSOR
• Generic Name: CORE TEMPERATURE SENSOR/CAPSULE
• Product Code: GWK
• Date Received: 2013-03-13
• Model Number: 500-0100-02
• Lot Number: 314250
• Device Expiration Date: 2013-03-01
• Operator: OTHER
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2013-03-13