MAUDE MDR 3010681

MDR report key
3010681
Report number
MW5029371
Event key
0
Event type
3
Date of event
2013-01-22
Date received
2013-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RESPIRONICS VITAL SENSE CAPSULE SENSORCORE TEMPERATURE SENSOR/CAPSULEGWK500-0100-02314250 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-1301. H

Event Narratives#

D

Patient 1

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.