MAUDE Adverse Event Report: SANOFI-AVENTIS SEPRAFILM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 12/13/2004

Event Type  Injury  

Event Description

Pt had multiple laparoscopic surgeries from 2000 until 2005.Pt received seprafilm during multiple of these surgeries, but only has a record of one of them.The purpose of these surgeries was lysis of adhesions following a surgery for endometriosis.On (b)(6) 2004 pt received seprafilm adhesion barrier during laparoscopic surgery.The adhesion barrier was noted in her operation report.During the operation, her doctor wrote that "the small bowel and omentum were completely free, but the rectosigmoid was quite tethered to the left adnexa and left lateral pelvic side wall.We placed a piece of adhesive barrier on the left side where the most dense adhesions were.We did this after irrigating and noting excellent hemostasis.We aspirated the irrigation fluid, placed the adhesion barrier and then decreased the co2." after this operation pt continued to experience symptoms of debilitating pain on the left side of lower abdomen, where the seprafilm was placed.Following the (b)(6) 2004 surgery, the pain became worse, not better.The pain is so debilitating that pt cannot work, pt cannot shower, pt can't do anything but sit here "in a pain prison" and watch tv.During a subsequent operation a year later ((b)(6) 2005), the surgeon wrote "dense adhesions of the left ovary to the fallopian tube, which is adhered to the left pelvic side wall as well as the sigmoid colon." the doctors have now told pt they can no longer operate, and she is on "pain management." in order to take a shower, pt has to take an opioid first, but the drugs are barely effective.The pain cuts right through fentanyl and oxycontin.Pt's bowel is so cemented to pelvic side wall that it cannot be removed.Pt reports horrific stabbing pain every time she moves her bowels, and does everything she can to avoid having a bowel movement (eating cheese, avoiding water, etc).She asks that the fda hold a public advisory committee meeting so she can testify.

• Brand Name: SEPRAFILM
• Type of Device: SEPRAFILM
• Manufacturer (Section D): SANOFI-AVENTIS
• MDR Report Key: 6053767
• MDR Text Key: 58397944
• Report Number: MW5065585
• Device Sequence Number: 1
• Product Code: MCN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CRESTOR FOR CHOLESTEROL; EFFEXOR FOR DEPRESSION 150MG; FENTANYL; OTC MEDS: CLARITIN FOR SEASONAL ALLERGIES; RX MEDS: OXYCONTIN; TRIAMTERENE 37.5/25; TYLENOL PM.
• Patient Outcome(s): Disability
• Patient Age: 42 YR
• Patient Weight: 66