SEPRAFILM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-12-13 for SEPRAFILM manufactured by Genzyme Corporation(framingham).

Event Text Entries

[187536958] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220423-2019-00026
• MDR Report Key: 9465301
• Report Source: FOREIGN,HEALTH PROFESSIONAL,L
• Date Received: 2019-12-13
• Date of Report: 2020-03-19
• Date Added to Maude: 2019-12-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DR. HEATHER SCHIAPPACASSE
• Manufacturer Street: 55 CORPORATE DRIVE, MS 55B-220 A
• Manufacturer City: BRIDGEWATER 08807
• Manufacturer Country: US
• Manufacturer Postal: 08807
• Manufacturer G1: GENZYME CORPORATION(FRAMINGHAM)
• Manufacturer Street: 76 NEW YORK AVENUE
• Manufacturer City: FRAMINGHAM 01701
• Manufacturer Country: US
• Manufacturer Postal Code: 01701
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SEPRAFILM
• Generic Name: MCN
• Product Code: MCN
• Date Received: 2019-12-13
• Lot Number: UNK
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GENZYME CORPORATION(FRAMINGHAM)
• Manufacturer Address: 76 NEW YORK AVENUE FRAMINGHAM 01701 US 01701

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-12-13