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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP ATRIUM C - QUR, V-PATCH (LARGE) 8.0CMX8.0CM, 3.2" X 3.2" ATRIUM C - QUR V-PATCH (LARGE)

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ATRIUM MEDICAL CORP ATRIUM C - QUR, V-PATCH (LARGE) 8.0CMX8.0CM, 3.2" X 3.2" ATRIUM C - QUR V-PATCH (LARGE) Back to Search Results
Model Number ATRIUM C-QUR V-PARCH
Event Date 02/28/2014
Event Type  Injury  
Event Description

Had a ventral incisional hernia repair done. Had a lot of pain post op-hives, rashes, redness, swelling at site within 8 days of implant, temp increase with wbc 23000 by day 10 post op. Had a hernia mesh repair-have repeated infections over and over not really ever recovered from. Admitted to hospital on (b)(6) 2014 with abdominal abscess. Surgery done culture said was (b)(6). Packed wound approx 6 weeks with dr giving antibiotics on and off. On (b)(6) 2014 went back to work in pain still. Dr gave antibiotics and i would feel better. In (b)(6), went to pcp and surgeon. Surgeon said this was scar tissue despite me telling him i thought was infection and when off antibiotics 5 days or so pain would come back. He gave me no more antibiotics. Said no more. Mid (b)(6) went back to him with swelling, redness, warmth with pain. Started snipping my scar open with pus oozing from it. I have been on antibiotics almost non-stop since (b)(6) to present. Surgeon sent me to another surgeon in bigger hospital. Snipping inside my belly button monthly continues and drainage continues. Was told had (b)(4) back in (b)(6) from culture. (b)(6) culture showed (b)(6) also or so did (b)(6) culture show scant amount (b)(6). I still experience pain daily, drainage, swelling and redness. I started developing a deformity (bulge) to area in (b)(6) 2014. I wear a hernia belt when i work to protect and support area affected.

 
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Brand NameATRIUM C - QUR, V-PATCH (LARGE) 8.0CMX8.0CM, 3.2" X 3.2"
Type of DeviceATRIUM C - QUR V-PATCH (LARGE)
Manufacturer (Section D)
ATRIUM MEDICAL CORP
MDR Report Key4540575
Report NumberMW5040823
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/01/2014
Device MODEL NumberATRIUM C-QUR V-PARCH
Device Catalogue Number31202
Device LOT Number10808442081

Patient TREATMENT DATA
Date Received: 02/19/2015 Patient Sequence Number: 1
Treatment
ANTIBIOTIC: DOXYCYCLINE 100 MG AB BIO
DISYCLOMINE HCL 10MG QD
VITAMIN C
LANSOPRAZOLE 30MG QD
POTASSIUM
FENOFIBRATE 160MG QD
SIMAVASTATIN 10MG QD
FOLIC ACID
FISHOIL
MULTIVITAMIN
LISINOPRIL HCTZ 20/25MG
81MG ASA (BABY)
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