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

Lot Number 06NP104

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

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); Anxiety (2328); Distress (2329); Injury (2348)

Event Type  Injury  

Event Description

Severe personal injury/permanent injuries [permanent injury].Bowel densely adherent to the mesh [bowel adhesions].Mental anguish [anguish].Severe emotional distress [emotional distress].Significant physical pain [pain].Case narrative: initial information received on 31-may-2019 from united states regarding an unsolicited legal valid serious case received from a lawyer.This case involves patient with unknown demographics who experienced bowel densely adherent to the mesh, severe personal injury/permanent injuries, mental anguish, severe emotional distress and significant physical pain, after having implant of the medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).The patient's past medical history included repair of ventral hernia on (b)(6) 2005 (lot number: 43kod268) with composix kugel was used in the surgery for the repair of ventral hernia.Patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2007, the patient underwent surgery for repair of recurrent complex ventral hernia and carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate was implanted (batch number-06np104) to repair the hernia defect.On (b)(6) 2015, patient underwent an additional surgery to excise the meshoma.It was observed that a very thick dinner plate type scar tissue containing the previously placed mesh, which surgeon incised and divided.In this course mesh was found and was noticed that bowel was densely adherent to the mesh which was taken down using sharp dissection enterotomy in small bowel.Surgeon also created anastomosis as well.After all the adhesions were taken down, the surgeon repaired the recurrent hernia and performed a reconstruction using ventralight st mesh.The event of bowel densely adherent to the mesh was assessed as serious due to criteria of medically significant.On the unknown date, patient experienced serious severe personal injury.This event was assessed as medically significant and was leading to surgical intervention.Patient experienced permanent injuries, severe mental anguish, severe emotional distress, significant physical pain and suffering.Patient lost wages, earning capacity and diminished quality of life.Final diagnosis was bowel densely adherent to the mesh, severe personal injury/permanent injuries, mental anguish, severe emotional distress and significant physical pain.Action taken: not applicable for bowel densely adherent to the mesh, severe personal injury/permanent injuries, mental anguish, severe emotional distress and significant physical pain.Corrective treatment: surgery for bowel densely adherent to the mesh and severe personal injury/permanent injuries; not reported for rest of the events.Outcome: unknown for bowel densely adherent to the mesh, severe personal injury/permanent injuries, mental anguish, severe emotional distress and significant physical pain.A product technical compliant was initiated and results were pending for same.

• 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: 8700292
• MDR Text Key: 148066475
• Report Number: 1221601-2019-00012
• 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
• Type of Report: Initial
• Report Date: 06/13/2019

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: 06NP104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2019
• 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; Required Intervention