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

[188588046] Intestinal obstruction (postoperative complication) [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 (21,22,23-nov-2019), 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 (postoperative complication), 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. 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 (postoperative complication) developed. On an unknown date, the outcome of intestinal obstruction (postoperative complication) was unknown. The patient developed an event of a serious intestinal obstruction (postoperative complication). This event was assessed as medically significant and was leading to intervention. Final diagnosis was intestinal obstruction (postoperative complication). It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for intestinal obstruction (postoperative complication). Reporter comment: not reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220423-2019-00027
• MDR Report Key: 9465265
• 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