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

Lot Number UNKNOWN

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Abscess (1690)

Event Type  Injury  

Event Description

Postoperative pelvic abscess [pelvic abscess].Case narrative: initial information received on 10-apr-2019 regarding an unsolicited valid serious case issued from a literature article.Title: 28: seprafilm does not adhere to robotic forceps.Authors: ota y, ando m, toeda m, teishikata y, ichikawa f, shirane t, et al.Journal: the 7th meeting of the japan society of gynecologic robotic surgery.2019; unk: 95.This case involves an unknown age female patient who experienced postoperative pelvic abscess, while she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, a camera port, 2 arms, and an assist port were used for robot assisted laparoscopic total hysterectomy (rash), and a right side docking was adopted.The vaginal stump was sutured longitudinally and continuously with an absorbable thread, while the retroperitoneum was not sutured, and carboxymethylcellulose/sodium hyaluronate was applied to the defective part of the peritoneum.On an unknown date, the patient required hospitalization for postoperative pelvic abscess.As of an unknown date, outcome of the postoperative pelvic abscess was unknown.The patient developed an event of a serious postoperative pelvic abscess.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.Final diagnosis was postoperative pelvic abscess.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for postoperative pelvic abscess.The action taken of seprafilm was unknown.Reporter comment: not reported.

Event Description

No adverse event.Case narrative: initial information received on 10-apr-2019 regarding an unsolicited valid non-serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 13-may-2019 and transmitted to sanofi.[literature information]: title: 28: seprafilm does not adhere to robotic forceps authors: ota y, ando m, toeda m, teishikata y, ichikawa f, shirane t, et al.Journal: the 7th meeting of the japan society of gynecologic robotic surgery.2019;unk:95.This case involves a 37 years old female patient who experienced no adverse event, while she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, a camera port, 2 arms, and an assist port were used for robot assisted laparoscopic total hysterectomy (rash), and a right side docking was adopted.The vaginal stump was sutured longitudinally and continuously with an absorbable thread, while the retroperitoneum was not sutured.On an unknown date, the patient required hospitalization for postoperative pelvic abscess.As of an unknown date, outcome of the postoperative pelvic abscess was unknown.Final diagnosis was no adverse event.Reporter comment: seprafilm was not used in the patient.Additional information was received on 13-may-2019 from the physician: confirmed that seprafilm was not used in the patient.Local comments: downgrade.

Event Description

No adverse event [no adverse event].Case narrative: initial information received on 10-apr-2019 regarding an unsolicited valid non-serious case received from (lp) japan-kaken lsa-pcp under reference 119311700201900508 on 13-may-2019 and transmitted to sanofi.[literature information].Title: 28: seprafilm does not adhere to robotic forceps authors: ota y, ando m, toeda m, teishikata y, ichikawa f, shirane t, et al.Journal: the 7th meeting of the japan society of gynecologic robotic surgery.2019;unk:95.This case involves a 37 years old female patient who experienced no adverse event, while she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, a camera port, 2 arms, and an assist port were used for robot assisted laparoscopic total hysterectomy (rash), and a right side docking was adopted.The vaginal stump was sutured longitudinally and continuously with an absorbable thread, while the retroperitoneum was not sutured.On an unknown date, the patient required hospitalization for postoperative pelvic abscess.As of an unknown date, outcome of the postoperative pelvic abscess was unknown.Final diagnosis was no adverse event.Reporter comment: seprafilm was not used in the patient.Additional information was received on 13-may-2019 from the physician: confirmed that seprafilm was not used in the patient.Additional information was received on 06-jun-2019 from full article and following changes were made: no new significant information received, case classification of non-case retained as in previous versions.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 8585894
• MDR Text Key: 144269532
• Report Number: 1220423-2019-00011
• 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,l
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 37 YR