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

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Ileus paralytic (pi) [ileus paralytic].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 10-dec-2019 and transmitted to sanofi.Title: o-14-5 study of ileus paralytic after intracorporeal urinary diversion in robot-assisted radical cystectomy author: kubota m, yamaguchi r, kokubun h, murata s, makita n, abe y, et al.Journal: the 33rd congress of japanese society of endourology, unk;unk:unk this case involves adult patient who experienced ileus paralytic (pi), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included bladder cancer, robot-assisted radical cystectomy (rarc) and intracorporeal urinary diversion (icud).The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient underwent robot-assisted radical cystectomy (rarc) and intracorporeal urinary diversion (icud) for bladder cancer.Prograsp forceps was used at introduction, then the surgical site was closed using endogia surgical stapler.Carboxymethylcellulose, sodium hyaluronate (dosage, unknown) was used for adhesion prophylaxis.On an unknown date, ileus paralytic (pi) developed.As of an unknown date, outcome of ileus paralytic (pi) was unknown.The patient developed an event of a serious ileus paralytic (pi) (ileus paralytic).This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus paralytic (pi).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus paralytic (pi).Reporter comment: the patient had been using seprafilm as of this stage.There was no causality between the event "ileus paralytic" and seprafilm.Additional information was received on 10-dec-2019 from the physician: changed causality as reported from related to not related.Updated reporter comment.

Event Description

Ileus paralytic (pi) [ileus paralytic].Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article: kubota m, yamaguchi r, kokubun h, murata s, makita n, abe y, et al.O-14-5 study of ileus paralytic after intracorporeal urinary diversion in robot-assisted radical cystectomy.The 33rd congress of japanese society of endourology.Unk; unk: unk.This case involves adult patient who experienced ileus paralytic (pi), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included bladder cancer, radical cystectomy and urostomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient underwent robot-assisted radical cystectomy (rarc) and intracorporeal urinary diversion (icud) for bladder cancer.Surgical instruments included forceps and endogia stapler.Seprafilm (carboxymethylcellulose, sodium hyaluronate) (amount, unknown; lot number, unknown) was used for adhesion prophylaxis.On an unknown date, ileus paralytic (pi) developed.As of an unknown date, outcome of ileus paralytic (pi) was unknown.The patient developed an event of a serious ileus paralytic (pi) (ileus paralytic).This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus paralytic (pi).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus paralytic (pi).Reporter comment: the patient had been using seprafilm as of this stage.There was no causality between the event "ileus paralytic" and seprafilm.Additional information was received on 10-dec-2019 from the physician: changed causality as reported from related 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 (id: (b)(4)) was received.Company comment was added.Correction to the previous report: narrative (including product lot number description) was updated.Additional information was received on 12-feb-2020: investigation summary (investigation summary #(b)(4), event id: (b)(4)) was obtained.Added reporter information.Correction to the previous report: corrected company comment (in the japanese field only).

Event Description

Ileus paralytic (pi) [ileus paralytic].Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article: kubota m, yamaguchi r, kokubun h, murata s, makita n, abe y, et al.O-14-5 study of ileus paralytic after intracorporeal urinary diversion in robot-assisted radical cystectomy.The 33rd congress of japanese society of endourology.Unk; unk: unk.This case involves adult patient who experienced ileus paralytic (pi), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included bladder cancer, radical cystectomy and urostomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient underwent robot-assisted radical cystectomy (rarc) and intracorporeal urinary diversion (icud) for bladder cancer.Surgical instruments included forceps and endogia stapler.Seprafilm (carboxymethylcellulose, sodium hyaluronate) (amount, unknown; lot number, unknown) was used for adhesion prophylaxis.On an unknown date, ileus paralytic (pi) developed.As of an unknown date, outcome of ileus paralytic (pi) was unknown.The patient developed an event of a serious ileus paralytic (pi) (ileus paralytic).This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus paralytic (pi).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus paralytic (pi).Reporter comment: the patient had been using seprafilm as of this stage.There was no causality between the event "ileus paralytic" and seprafilm.Additional information was received on 10-dec-2019 from the physician: changed causality as reported from related 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 (id: (b)(4)) was received.Company comment was added.Correction to the previous report: narrative (including product lot number description) was updated.

Event Description

Ileus paralytic (pi) [ileus paralytic].Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article: kubota m, yamaguchi r, kokubun h, murata s, makita n, abe y, et al.O-14-5 study of ileus paralytic after intracorporeal urinary diversion in robot-assisted radical cystectomy.The 33rd congress of japanese society of endourology.Unk; unk: unk.This case involves adult patient who experienced ileus paralytic (pi), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included bladder cancer, radical cystectomy and urostomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient underwent robot-assisted radical cystectomy (rarc) and intracorporeal urinary diversion (icud) for bladder cancer.Surgical instruments included forceps and endogia stapler.Seprafilm (carboxymethylcellulose, sodium hyaluronate) (amount, unknown; lot number, unknown) was used for adhesion prophylaxis.On an unknown date, ileus paralytic (pi) developed.As of an unknown date, outcome of ileus paralytic (pi) was unknown.The patient developed an event of a serious ileus paralytic (pi) (ileus paralytic).This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus paralytic (pi).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus paralytic (pi).Reporter comment: the patient had been using seprafilm as of this stage.There was no causality between the event "ileus paralytic" and seprafilm.Additional information was received on 10-dec-2019 from the physician: changed causality as reported from related 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 (id: (b)(4)) was received.Company comment was added.Correction to the previous report: narrative (including product lot number description) was updated.Additional information was received on 12-feb-2020: investigation summary (investigation summary #(b)(4), event id: (b)(4)) was obtained.Added reporter information.Correction to the previous report: corrected company comment (in the japanese field only).

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 9465301
• MDR Text Key: 187536958
• Report Number: 1220423-2019-00026
• 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
• Report Date: 03/19/2020

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: 12/13/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/06/2020; 02/26/2020; 03/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention