MAUDE MDR 1562934

MDR report key
1562934
Report number
MW5014015
Event key
0
Event type
3
Date of event
2009-08-19
Date received
2009-12-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1STAMEN PUMPNONESTAMEN'SLST N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-1601. D

Event Narratives#

D

Patient 1

MY HUSBAND USED A PUMP DEVICE FOR ERECTILE DYSFUNCTION THREE DAYS BEFORE HE SUFFERED A VERY VERY BAD STROKE AND THEN, BLED ON TOP OF THE STROKE. THIS WAS THE ONE AND ONLY TIME HE HAD USED THE DEVICE! HE HAD BEEN WALKING 2 1/2 MILES MOST EVERY DAY AND HAD LOST WEIGHT ON PURPOSE. HE WAS AN ACTIVE PERSON WHO WOULD GO FISHING ANYTIME INVITED. HE TOOK CARE OF ME FOR 9 MONTHS WHILE I WAS HEALING FROM A BROKEN LEG/ANKLE! HE FOUGHT VALIANTLY TO STAY ALIVE FOR 13 DAYS. HE GAVE UP THE FIGHT AT 2PM IN THE AFTERNOON. I DIDN'T THINK TO SHARE THIS INFO WITH HIS DRS. AT THE HOSPITAL - I DIDN'T PUT 2 AND 2 TOGETHER UNTIL RECENTLY---I WOULDN'T BE SURPRISED IF OTHER MEN DIE FROM USING THIS DEVICE. I REMEMBER HOW STRESSFUL IT WAS FOR HIM TO USE IT AND HOW HE EXERTED HIMSELF. I HAVE TOLD THE MANUFACTURER - VIA PHONE - OF MY SUSPICIONS. I HOPE THIS DEVICE WILL BE PULLED FROM THE MARKET PLACE BEFORE ANY MORE FAITHFUL HUSBANDS DIE FROM TRYING TO RECAPTURE THEIR YOUTH! DIAGNOSIS OR REASON FOR USE: ERECTILE DYSFUNCTION.