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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Infection after oesophageal hiatal hernia surgery [postoperative wound infection] ([wound dehiscence], [device use error]).Case narrative: initial information received on 23-jan-2020 regarding an unsolicited valid serious case received from (b)(6) under reference on 23-jan-2020 and transmitted to sanofi.This case is linked to cases (b)(4).This case involves adult patient who experienced infection after oesophageal hiatal hernia surgery, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included hiatus hernia and abdominal hernia repair.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm (carboxymethylcellulose, sodium hyaluronate) was used for preventing peritoneal adhesion after oesophageal hiatal hernia surgery.Wound dehiscence due to infection after oesophageal hiatal hernia surgery developed, and vinyl was exposed.Emergency laparotomy was performed.Outcome of vinyl was exposed, abdominal wall wound was dehisced, and infection after oesophageal hiatal hernia surgery was unknown.The patient developed an event of a serious infection after oesophageal hiatal hernia surgery.This event was assessed as medically significant and was leading to intervention.The patient developed an event of a serious abdominal wall wound was dehisced.This event was assessed as medically significant and was leading to intervention.The patient developed an event of a serious vinyl was exposed.This event was assessed as medically significant and was leading to intervention.Final diagnosis was infection after oesophageal hiatal hernia surgery.An unknown corrective treatment was received.The patient outcome is reported as unknown for infection after oesophageal hiatal hernia surgery, as unknown for abdominal wall wound was dehisced and as unknown for vinyl was exposed.Reporter comment: not reported.

Event Description

Infection after oesophageal hiatal hernia surgery [postoperative wound infection] ([wound dehiscence], [device use error]).Case narrative: initial information received on 23-jan-2020 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference on 07-feb-2020 and transmitted to sanofi.This case is linked to cases (b)(4).This case involves a 10's year old male patient who experienced infection after oesophageal hiatal hernia surgery, while he using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included hiatus hernia (recovery status was unknown) and abdominal hernia repair.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing gastric fistula.On an unknown date (when the patient underwent a surgery), seprafilm (carboxymethylcellulose, sodium hyaluronate) was used for preventing intraperitoneal adhesion after the oesophageal hiatal hernia surgery, in which seprafilm (12.7 x 7.35 cm) was cut into long, narrow pieces (the amount of seprafilm used was unknown).During this procedure, the area was contaminated with a plastic material of seprafilm's outer package.Eight days after the oesophageal hiatal hernia surgery, it was found that postoperative infection led to wound dehiscence on a surface of the intestinal tract, and the plastic material (vinyl) was found there.The plastic material was removed.Because of an undeniable possibility of any other residual foreign material, an emergency re-laparotomy was performed.During this re-laparotomy, no foreign object was found in the abdominal cavity, and it was discovered that the wound infection was caused by an accidental dislodgement of gastric fistula.Intraperitoneal drainage and abdominal wall plasty were performed.It was reported that "excessive treatment" was given for the reported incident, and that the possibility of the incident's causing any disorder in the future was undeniable (but low).On an unknown date, the outcome of the events "vinyl was exposed", "abdominal wall wound was dehisced", and "infection after oesophageal hiatal hernia surgery" was unknown.The patient developed an event of a serious infection after oesophageal hiatal hernia surgery (postoperative wound infection).This event was assessed as medically significant and was leading to intervention.The patient developed an event of a serious abdominal wall wound was dehisced (wound dehiscence).This event was assessed as medically significant and was leading to intervention.The patient developed an event of a serious vinyl was exposed (device use error).This event was assessed as medically significant and was leading to intervention.Final diagnosis was infection after oesophageal hiatal hernia surgery.An unknown corrective treatment was received.The patient outcome is reported as unknown for infection after oesophageal hiatal hernia surgery, as unknown for abdominal wall wound was dehisced and as unknown for vinyl was exposed.Reporter comment: the infection following the oesophageal hiatal hernia surgery was found to be the wound infection caused by an accidental dislodgement of gastric fistula.Regarding the contamination with the plastic material, an analysis is difficult; even experienced and educated surgeon was unable to avoid the contamination, as seprafilm, which was cut into long, narrow pieces, and its outer pouch are both transparent.Additional information was received on 07-feb-2020 from the physician: updated patient information, updated reporter comment, updated medical history, changed indication of seprafilm (japanese only), changed event term (japanese only), and updated narrative.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 9659443
• MDR Text Key: 191896167
• Report Number: 1220423-2020-00005
• 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,Followup
• 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: 02/03/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention