MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAMESH) SEPRAMESH IP; MCN

Lot Number UNKNOWN

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

Patient Problems Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2007

Event Type  Injury  

Event Description

Unable to work [inability to work].Bowel blockage [bowel obstruction].Fluid pouring from the site [post procedural persistent drain fluid].Pain [implant site pain].Sickness [sickness].Unable to eat [unable to eat].Case narrative: initial information was received from canada on 05-oct-2023 regarding an unsolicited valid serious case from a patient (retired nurse).This case involves an unknown age female patient who was unable to work, bowel blockage, fluid pouring from the site, pain, sickness and unable to eat after the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).In 2006, the patient was diagnosed with grapefruit size ovarian cyst.It was removed but luckily, it was not cancerous.She had a complication, so an open surgery was performed, scaring was taken down and the problem solved.A few days later she had a large hernia had pushed through in the mid-line near the ribs.The patient never had hernia before.The patient was told the hernia would have to be repaired.The patient sent back for surgery to repair this hernia.The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.In 2007, the patient received sepramesh ip (carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate) implant once during abdominal hernia repair (batch number, expiry date, strength).Information on batch number and expiry date was requested.The patient was not informed that mesh was going to used.She thought hernia would be repaired like with her own tissues and sutures.In 2007, after unknown latency, the pain and problems started.It all started the sickness (illness), and pain (implant site pain) that haunt her into this day.She was unable to work (impaired work ability, leading to disability), in bed most days, unable to eat feeding disorder) and the worst was the surgeon refused to see her.She had fluid pouring from the site (post procedural persistent drain fluid).She was put on pain medication low dose of morphine and lorazepam.She was having bowel blockage (intestinal obstruction, medically significant) (onset date: 2007, latency: unknown for all the events).She had test after test, but nothing showed up.Life had been hell.She found out 10 years later (approx.2017) that she had genzyme sepramesh ip composite.She was on pain medications, still now plastic bags plus or being pulled off but still she had plastic inside (sepramesh ip) her.She said plastic was not compatible in humans.No test was done, but just on a rat.She had seen doctors but was refused to have it removed.It ruined her life.Action taken: not applicable for all the events.Corrective treatment: low dose of morphine and lorazepam for pain, not reported for rest all events.At time of reporting, the outcome was not recovered for the event pain, was unknown for rest all events.

• Brand Name: SEPRAMESH IP
• Type of Device: MCN
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAMESH); 76 new york avenue; framingham 01701
• Manufacturer (Section G): GENZYME BIOSURGERY (SEPRAMESH); 76 new york avenue; framingham 01701
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 17950141
• MDR Text Key: 325897982
• Report Number: 1221601-2023-00001
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/17/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Sex: Female