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

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

Patient Problem Adhesion(s) (1695)

Event Type  Injury  

Event Description

Intestinal obstruction (clavien-dindo classification grade iiia) [intestinal obstruction].Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article.Title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.Author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology, unk;unk:unk.This case was issued in publication in which another related case was reported: (b)(4) (cluster).This case involves adult patient who experienced intestinal obstruction (clavien-dindo classification grade iiia), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Medical history: laparoscopic total cystectomy.On an unknown date, seprafilm was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (clavien-dindo classification grade iiia) developed.On an unknown date, an ileus tube was placed and the patient improved.The intestinal obstruction (clavien-dindo classification grade iiia) was resolving.The patient developed an event of a serious intestinal obstruction (clavien-dindo classification grade iiia).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (clavien-dindo classification grade iiia).An unknown corrective treatment was received.The patient outcome is reported as recovering / resolving for intestinal obstruction (clavien-dindo classification grade iiia).Reporter comment: not reported.

Event Description

Intestinal obstruction (clavien-dindo classification grade iiia).Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference on 12-dec-2019 and transmitted to sanofi.Title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.Author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology, unk;unk:unk.This case was issued in publication in which another related case was reported: (b)(4) (cluster).This case involves adult patient who experienced intestinal obstruction (clavien-dindo classification grade iiia), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Medical history: laparoscopic total cystectomy.On an unknown date, seprafilm was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (clavien-dindo classification grade iiia) developed.On an unknown date, an ileus tube was placed and the patient improved.The intestinal obstruction (clavien-dindo classification grade iiia) was resolving.The patient developed an event of a serious intestinal obstruction (clavien-dindo classification grade iiia) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (clavien-dindo classification grade iiia).An unknown corrective treatment was received.The patient outcome is reported as recovering / resolving for intestinal obstruction (clavien-dindo classification grade iiia).Reporter comment: because of paralytic intestinal obstruction, the event "intestinal obstruction (clavien-dindo classification grade iiia)" is not related to seprafilm.Additional information was received on 12-dec-2019 from the physician: changed the causality assessment by reporter to "not related".Updated reporter comment.

Event Description

Intestinal obstruction (clavien-dindo classification grade iiia) [intestinal obstruction] case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.O-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.The 33rd congress of japanese society of endourology.Unk; unk: unk.This case was issued in publication in which another related case was reported: (b)(4)(cluster).This case involves an adult patient who experienced intestinal obstruction (clavien-dindo classification grade iiia), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy (laparoscopic total cystectomy).The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm (lot number: unknown) was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (clavien-dindo classification grade iiia) developed.On an unknown date, an ileus tube was placed and the patient improved.The intestinal obstruction (clavien-dindo classification grade iiia) was resolving.The patient developed an event of a serious intestinal obstruction (clavien-dindo classification grade iiia) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (clavien-dindo classification grade iiia).An unknown corrective treatment was received.The patient outcome is reported as recovering / resolving for intestinal obstruction (clavien-dindo classification grade iiia).Reporter comment: because of paralytic intestinal obstruction, the event "intestinal obstruction (clavien-dindo classification grade iiia)" is not related to seprafilm.Additional information was received on 12-dec-2019 from the physician: changed the causality assessment by reporter to "not related".Updated reporter comment.Additional information was received on 17-dec-2019: no new information was received.Additional information was received on 23-jan-2020: comet complaint case summary (comet complaint id: (b)(4)) was added.Correction to the previous report: narrative was updated.Additional information was received on 12-feb-2020: investigation summary was received from gqp quality operations, industrial affairs, quality information management (investigation summary no.(b)(4), event id (b)(4)).Correction to the previous report: corrected company comment (japanese only).

Event Description

Intestinal obstruction (clavien-dindo classification grade iiia) [intestinal obstruction] case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article: title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.Author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology, unk;unk:unk.This case was issued in publication in which another related case was reported: (b)(4) (cluster).This case involves adult patient who experienced intestinal obstruction (clavien-dindo classification grade iiia), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Medical history: laparoscopic total cystectomy.On an unknown date, seprafilm (lot number: unknown) was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (clavien-dindo classification grade iiia) developed.On an unknown date, an ileus tube was placed and the patient improved.The intestinal obstruction (clavien-dindo classification grade iiia) was resolving.The patient developed an event of a serious intestinal obstruction (clavien-dindo classification grade iiia) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (clavien-dindo classification grade iiia).An unknown corrective treatment was received.The patient outcome is reported as recovering / resolving for intestinal obstruction (clavien-dindo classification grade iiia).Reporter comment: because of paralytic intestinal obstruction, the event "intestinal obstruction (clavien-dindo classification grade iiia)" is not related to seprafilm.Additional information was received on 12-dec-2019 from the physician: changed the causality assessment by reporter to "not related".Updated reporter comment.Additional information was received on 17-dec-2019: no new information was received.Additional information was received on 23-jan-2020: comet complaint case summary (comet complaint id: (b)(4)) was added.Correction to the previous report: narrative was updated.

Manufacturer Narrative

(b)(4).

Event Description

Intestinal obstruction (clavien-dindo classification grade iiia) [intestinal obstruction] case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.O-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.The 33rd congress of japanese society of endourology.Unk; unk: unk.This case was issued in publication in which another related case was reported: (b)(4) (cluster).This case involves an adult patient who experienced intestinal obstruction (clavien-dindo classification grade iiia), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy (laparoscopic total cystectomy).The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm (lot number: unknown) was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (clavien-dindo classification grade iiia) developed.On an unknown date, an ileus tube was placed and the patient improved.The intestinal obstruction (clavien-dindo classification grade iiia) was resolving.The patient developed an event of a serious intestinal obstruction (clavien-dindo classification grade iiia) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (clavien-dindo classification grade iiia).An unknown corrective treatment was received.The patient outcome is reported as recovering / resolving for intestinal obstruction (clavien-dindo classification grade iiia).Reporter comment: because of paralytic intestinal obstruction, the event "intestinal obstruction (clavien-dindo classification grade iiia)" is not related to seprafilm.Additional information was received on 12-dec-2019 from the physician: changed the causality assessment by reporter to "not related".Updated reporter comment.Additional information was received on 17-dec-2019: no new information was received.Additional information was received on 23-jan-2020: comet complaint case summary (comet complaint id: (b)(4) was added.Correction to the previous report: narrative was updated.Additional information was received on 12-feb-2020: investigation summary was received from (b)(4) (investigation summary no.(b)(4), event id (b(4)).Correction to the previous report: corrected company comment (japanese only).

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 9465293
• MDR Text Key: 188587147
• Report Number: 1220423-2019-00028
• 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,Followup,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention