MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Injury (2348)

Event Date 12/13/2004

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 23-nov-2016: this case concerns a patient who experienced lower abdominal pain and dense postoperative adhesions following the use of seprafilm.Based upon the information provided a positive temporal relationship can be established hence the causal role product cannot be denied from the occurrence of the events.Since the patient had a history of postoperative adhesions before the use of seprafilm, it acts a confounding factor for assessing the causal role.Furthermore the history of multiple surgeries acts as a predisposing factor in the causation of the events.Lack of information regarding postoperative care received by the patient also precludes the complete case assessment.

Event Description

Debilitating pain in the left side of lower abdomen where seprafilm was placed/horrifying stabbing pain every time she moves her bowels [abdominal pain lower] 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 [postoperative adhesion].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on 15-nov-2016 from a non-healthcare professional via health authority of united states (usa-fda with regulatory reference number: mw5065585).This case involves a female patient of unknown age who had placement of seprafilm and the same day experienced debilitating pain in the left side of lower abdomen where seprafilm was placed/horrifying stabbing pain every time she moves her bowels and after unknown latency had 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 patient had multiple laparoscopic surgeries from 2000 and received seprafilm during multiple of these surgeries.The purpose of these surgeries was lysis of adhesions following a surgery for endometriosis.The concomitant medications were rosuvastatin calcium (crestor) for cholesterol, triamterene and venlafaxine hydrochloride (effexor) for depression, loratadine (claritin) for seasonal allergies and paracetamol (tylenol).No concurrent condition was reported.On (b)(6) 2004, the patient underwent laparoscopic surgery, seprafilm (dose, form, route, batch/lot number and expiration date: unknown) was applied as postoperative adhesion.The adhesion barrier was noted in the operation report.During the operation, the doctor noted that the small bowel and omentum were completely free, but the recto-sigmoid was quite tethered to the left adnexa and left lateral pelvic side wall.A piece of adhesive barrier was placed on the left side where the most dense adhesions were.This was done after irrigating and noting excellent hemostasis.The irrigation fluid was aspirated, the adhesion barrier was placed and then the carbon dioxide (c02) was decreased.After the operation, the patient continued to experience symptoms of debilitating pain on the left side of lower abdomen, where the seprafilm was placed.Following the surgery, the pain became worse, not better.The pain was so debilitating that the patient could not work, shower or do anything but sit there "in a pain prison" and watch tv.On an unknown date in 2005, after unknown latency, during a subsequent operation a year later, the surgeon noted dense adhesions of the left ovary to the fallopian tube, which was adhered to the left pelvic side wall as well as the sigmoid colon.The doctors then told the patient that they could no longer operate, and she was on "pain management.It was reported that in order to take a shower, the patient had to take an opioid first, but the drugs were barely effective.The pain cut right through fentanyl and oxycodone hydrochloride (oxycontin).The patient's bowel was so cemented to pelvic side wall that it could not be removed.The patient reported horrific stabbing pain every time she moved her bowels, and did everything she could to avoid.Corrective treatment: pain management, opioids, fentanyl and oxycodone hydrochloride for debilitating pain in the left side of lower abdomen where seprafilm was placed/horrifying stabbing pain every time she moves her bowels; not reported for 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.Outcome: unknown for both the events.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criterion: disability for both the events.Pharmacovigilance comment: sanofi company comment dated 23-nov-2016: this case concerns a patient who experienced lower abdominal pain and dense postoperative adhesions following the use of seprafilm.Based upon the information provided a positive temporal relationship can be established hence the causal role product cannot be denied from the occurrence of the events.Since the patient had a history of postoperative adhesions before the use of seprafilm, it acts a confounding factor for assessing the causal role.Furthermore the history of multiple surgeries acts as a predisposing factor in the causation of the events.Lack of information regarding postoperative care received by the patient also precludes the complete case assessment.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer (Section G): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 10453928
• MDR Text Key: 213196385
• Report Number: 1220423-2020-00016
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 08/26/2020

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: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability