WOUND VAC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-06 for WOUND VAC manufactured by Kci, Inc..

Event Text Entries

[1414423] Had femoral artery bypass surgery in 2004 at the hospital that got infected and was removed. I had a massive infection. Was in icu and the hospital about 3 weeks. I was treated with iv antibiotics until -according to my doctor- my white cell count got down to normal. I was left with a huge bulging hernia that made me look like i was pregnant. Md said my abdominal muscles had been "shredded" as a result of 2 surgeries an place. Within a couple of months, i was having weight, mobility, balance and back problems. In 2005, the surgeon put in a hole in my stomach and put in a big piece of mesh to help hold my guts in. I seem to remember i was in the hospital for about 1 - 1. 5 weeks and at home for a week or so until i had the staples taken out. Leaving the doctor's office, a hole opened up and i had pus running everywhere. The md put me on antibiotics for a week or two and then put me on a wound vac machine from kci. To the best of my memory, this went on for around 3-4 more months. At first, the hole seemed to get smaller in diameter then it seemed to stay the same and got a little bigger. I was pumping between 1 and 2 canisters full of creamy yellowish looking stuff out of that hole every 24 hours -usually about 1. 5-. I stayed really weak and tried all the time and would sometimes get sicker. A time or two, the md would put me on antibiotics and i would get better, and the stuff being pumped out would decrease in volume and look clearer and more pinkish but it would always go back to the thick creamy yellowish color -kind of like cream of chicken soup. In 2005, it became obvious that the wound vac wasn't doing much good and my insurance company was getting tired of paying -a lot- and without capital health plan being willing to pay for the wound vac, the home nursing ground to a halt. My doctor hung in with me but didn't seem to want to do much except "wait and see" or didn't know what to do. I think that without the wound vac to pump out the pus, the infection got a lot worse a lot quicker. I got a referral to another facility to get the mesh taken out and by the time i got there, i was so sick that i was admitted 24 hours sooner than i was scheduled to be admitted and got the mesh taken out and was treated again with iv antibiotics until the infection cleared up. Not to long after that, i got a skin graft to cover up the hole in my stomach. Now i have a small bowling ball size hernia on my lower left abdomen and a hole in my stomach about 6-8 inches across and 1-2 inches deep. My back hurts a lot and can't walk far at one time and my balance is way off and i've put on a ton of weight i can't get off - but i am alive and i'm not sick and as weak as i was all of that summer. Frequency: 24/7. Route: other. Dates of use: 4 months. Diagnosis or reason for use: surgical wound. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5014261
MDR Report Key1574894
Date Received2010-01-06
Date of Report2010-01-06
Date of Event2005-08-01
Date Added to Maude2010-01-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameWOUND VAC
Product CodeOKO
Date Received2010-01-06
Returned To Mfg2005-01-01
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerKCI, INC.
Manufacturer AddressKANSAS CITY KS US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other; 3. Required No Informationntervention 2010-01-06

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