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

[188587147] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220423-2019-00028
• MDR Report Key: 9465293
• Report Source: FOREIGN,HEALTH PROFESSIONAL,L
• Date Received: 2019-12-13
• Date of Report: 2020-02-17
• 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