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

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

Patient Problems Wound Dehiscence (1154); Fatigue (1849); Fistula (1862); Headache (1880); Unspecified Infection (1930); Nausea (1970); Pain (1994); Pneumonia (2011); Vomiting (2144); Coma (2417); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 10-jun-2016: this case concerns a patient who received seprafilm and developed wound dehiscence, fistula, multiple infections including pneumonia, intussusception, delayed wound healing and coma afterwards.Based upon the information provided, the causal role of seprafilm in the causation of the events cannot be denied as there is a positive temporal relationship.However, lack of information regarding the patient's post-operative surgical care, conditions under which seprafilm was applied, the purpose of seprafilm application (indication) ,and relevant medical history precludes the complete case assessment.

Event Description

Med induced coma; pneumonia; multiple infections, infection nos; intussusception; intussusception; large open wound not healing; wound healing delayed; product led to abdomen mid-line incision from mid of ribs to pelvis bone splitting open, got to see insides; wound dehiscence; fistula; growth (bulges)/abdomen swelling; severe pain; tired; muscle atrophy; weakness; pain in legs; headaches; digestive issues (gastrointestinal disorder nos) nausea; vomiting.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 27-may-2016 from a patient via health authority of united states (usa-fda with regulatory reference number: mw5061989).This case concerns a patient of unknown demographics who experienced med induced coma, pneumonia, multiple infections, intussusception, large open wound not healing, fistula, growth (bulges)/abdomen swelling, severe pain, tired, muscle atrophy, weakness, pain in legs, headaches, digestive issues, nausea, and vomiting after placement of seprafilm, and the product led to abdomen mid-line incision from mid of ribs to pelvis bone splitting open, got to see insides.No relevant past drugs, and concurrent conditions were reported.The concomitant medications were oxycodone, potassium chloride (k-dur), sertraline hydrochloride (zoloft), clonazepam, propranolol (propanolol), furosemide (lasix), procaterol hydrochloride (pro-air), salbutamol (albuterol), esomeprazole (nexium), atomoxetine hydrochloride (strattera), ibuprofen (motrin), nebulizer, over the counter (otc) medicine, multivitamin and heating pad.On an unknown date in jul-2013, the patient underwent a surgery for intestinal kink/blockage (removed a 10 cm section).On (b)(6) 2013, about 8-10 days after surgery, the patient had placement of intra-abdominal seprafilm once (indication, batch/lot number and expiration date: unknown).On (b)(6) 2013, the product led to patient's abdomen mid-line incision from mid of ribs to pelvis bone, splitting it open so that the patient got to see the insides.On unknown dates in 2013, the patient had multiple infections, fistulas, pneumonia and intussusception and received blood transfusions.The large open wound was not healing and the patient had multiple surgeries over the course of more than a year with the nurse coming to patient's home 2 times per week.On an unknown date, the patient had med induced coma.The patient received intravenous (iv) bags of total parenteral nutrition (tpn) to assist in keeping the patient alive.The patient had every antibiotic that they had, even the one that could not be exposed to light.It was reported that the patient had growths (bulges), abdomen swelling, severe pain and digestive issues.A part of patient's intestine slid into another part of the intestine like a telescope.It was reported that one cause of this was from surgery on the intestinal tract.The patient was always very tired, had muscle atrophy, weakness, pain in legs, inability to stand at times due to pain in legs, nausea, vomiting and headaches.Corrective treatment: tpn for med induced coma, antibiotics for pneumonia, antibiotics and blood transfusions for multiple infections, surgery for intussusception, large open wound not healing, product led to abdomen midline incision from mid of ribs to pelvis bone splitting open, got to see insides, fistula; not reported for rest of the events.Outcome: recovered for the event of med induced coma; unknown for rest of the events.A pharmaceutical technical complaint (ptc) was initiated, and conclusion was pending for the same.Seriousness criteria: life threatening, hospitalization, disability, important medical event (ime), required intervention for med induced coma, pneumonia, multiple infections, intussusception, large open wound not healing, product led to abdomen mid-line incision from mid of ribs to pelvis bone splitting open, got to see insides and fistula.Pharmacovigilance comment: sanofi company comment dated 10-jun-2016, "this case concerns a patient who received seprafilm and developed." wound dehiscence, fistula, multiple infections including pneumonia, intussusception, delayed wound healing and coma afterwards.Based upon the information provided, the causal role of seprafilm in the causation of the events cannot be denied as there is a positive temporal relationship.However, lack of information regarding the patient's post-operative surgical care, conditions under which seprafilm was applied, the purpose of seprafilm application (indication) and relevant medical history 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: 10453946
• MDR Text Key: 212511941
• Report Number: 1220423-2020-00017
• 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: consumer
• 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: No Information
• 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): Hospitalization; Life Threatening; Other; Required Intervention; Disability