FDA.reportPublic FDA data

MAUDE MDR 806231

MDR report key
806231
Report number
3021763-2007-00001
Event key
0
Event type
3
Date of event
2006-08-01
Date received
2007-01-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1011 SW EMKAY DR # 104 BEND OR 97702 US
Phone
541-541-5413
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MYSELFPERINEOMETER, 884.1425DESCHUTES MEDICAL PRODUCTS, INC.HCCNANANANRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-01-1601. O

Event Narratives#

D

Patient 1

USER DESCRIBED EVENT AS FOLLOWS: "I WAS USING THE MYSELF BIOFEEDBACK DEVICE ACCORDING THE DIRECTIONS. THAT IS PUMPING AIR INTO THE SENSOR UNTIL THE LCD DISPLAY TELLS ME TO STOP. THEN TIGHTENING MUSCLE UNITL THE BIOFEEDBACK DISPLAY TELLS ME TO RELAX. WHEN DOING THIS I FELT A SUDDEN PAIN AND TWINGE. A LUMP PROTRUDED LOW ON MY ABDOMEN. I HAVE SEEN A DOCTOR ABOUT THIS, IT IS AN INGUINAL HERNIA."