FDA.reportPublic FDA data

MAUDE MDR 790818

MDR report key
790818
Report number
MW1041260
Event key
0
Event type
3
Date of event
2006-08-01
Date received
2006-12-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MYSELFMYSELFDESCHUTES MEDICAL PRODUCTS INC.HCC***NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-12-0501. O

Event Narratives#

D

Patient 1

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