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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORBAFIX NONE

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SORBAFIX NONE Back to Search Results
Lot Number HUVJ0760
Event Date 02/24/2012
Event Type  Injury  
Event Description

Had bi-lateral hernia surgery with mesh implanted. One large piece of bard 3d mesh used to cover a femoral and inguinal hernia together on the right, and another large piece used to cover two inguinal hernias on the left. Bard 3d max lot huvi0120 and huvj0718 and sorbafix lot huvj0760. Since (b)(6) weeks after surgery, have had tremendous pain in right pelvis to pubic bone and down front of leg, and some burning pain in left pelvis. Also had surgical clips used to hold right peritoneum closed. Surgical report says it "opened during the surgery. ".

 
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Brand NameSORBAFIX
Type of DeviceNONE
MDR Report Key2660967
Report NumberMW5026193
Device Sequence Number3
Product CodeFTL
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/15/2012
3 DeviceS WERE Involved in the Event: 1   2   3  
1 Patient Was Involved in the Event
Date FDA Received07/15/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device LOT NumberHUVJ0760
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 07/15/2012 Patient Sequence Number: 1
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