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

Device Problem Use of Device Problem (1670)

Patient Problems Wound Dehiscence (1154); Meningitis (2389); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Meningitis bacterial [meningitis bacterial].Dehiscence of the wound in the abdominal wall [wound dehiscence].Exposure of vinyl (residual foreign body in abdominal cavity) [device use error].Case narrative: initial information received on 23-jan-2020 regarding an unsolicited valid serious case received from (lp) (b)(4)-kaken lsa-pcp under reference on (b)(6) 2020 and transmitted to sanofi.This case is linked to cases (b)(4).This case involves (b)(6) years old male patient who experienced meningitis bacterial, dehiscence of the wound in the abdominal wall and exposure of vinyl (residual foreign body in abdominal cavity), while he using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included mechanical ileus and intestinal adhesion lysis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Notes: inpatient.Strangulation ileus (state of cure was unknown).The patient's condition immediately before the use of seprafilm: under the influence of drugs.On an unknown date, adhesiolysis was performed for strangulated ileus.The scrub nurse cut seprafilm into 5-cm square pieces for each outer package at the discretion of the physician and handed them to a surgeon.Seprafilm (dosage: unknown, lot number: unknown) was used to prevent intra-abdominal adhesion after surgery for strangulation ileus.As usual, the surgery was completed after counting the number of gauzes, equipment and needles.On an unknown date, meningitis bacterial developed.At the outpatient visit after the adhesiolysis for strangulated ileus, a small dehiscence of the wound in the abdominal wall occurred and vinyl was exposed (transparent film was exposed from the abdominal wall.A foreign body remained in the abdominal cavity.) since the wound dehiscence increased, it was decided that an emergency resection would be performed.In the operating room, laparotomy was performed again under general anesthesia and the foreign body (outer package of seprafilm) was removed.Degree of treatment for accident: intensive treatment.Degree of accident: no possibility of residual disorder.On an unknown date, the outcome of dehiscence of the wound in the abdominal wall and meningitis bacterial was unknown.The outcome of exposure of vinyl (residual foreign body in abdominal cavity) was not applicable (unknown).The patient developed an event of a serious meningitis bacterial.This event was assessed as medically significant and was leading to intervention.The patient developed an event of a non-serious dehiscence of the wound in the abdominal wall (wound dehiscence).The patient developed an event of a non-serious exposure of vinyl (residual foreign body in abdominal cavity) (device use error).Final diagnosis was exposure of vinyl (residual foreign body in abdominal cavity), dehiscence of the wound in the abdominal wall and meningitis bacterial.An unknown corrective treatment was received.The patient outcome is reported as unknown for dehiscence of the wound in the abdominal wall, as not applicable for exposure of vinyl (residual foreign body in abdominal cavity) and as unknown for meningitis bacterial.Reporter comment: [dehiscence of the wound in the abdominal wall].Causality with seprafilm: unknown.Other causative factor suspected: unknown.[exposure of vinyl (residual foreign body in abdominal cavity)].Causality with seprafilm: unknown.Causative factor: the outer package of seprafilm was cut to protect the product, and the outer package was forgotten to be removed.Seprafilm was used in the abdominal cavity without be noticing that the outer package was mixed with the product.Background factor: human error.Additional information was received on 07-feb-2020 from the physician: changed medical history.Updated information on the adverse events.Updated clinical course and reporter comment.Added company comment.

• 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: 9721481
• MDR Text Key: 194839285
• Report Number: 1220423-2020-00012
• 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
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 02/13/2020

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: 02/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention