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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEPRAFILM; MCN
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SEPRAFILM; MCN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
Ileus [ileus].Case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article in the scope of post-marketing sponsored study: title: study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach.Authors: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.Journal: the 73rd annual meeting of the japan esophageal society.2019; unk: 135.Center id: unk; patient id: unknown; country: (b)(6).Study title: unsponsored study involving seprafilm.This case was issued in publication in which 5 other related cases were reported: (b)(4) (cluster).This case involves adult patient who experienced ileus, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm (number of sheets unknown) was used for laparotomy.On an unknown date, ileus developed.Outcome of ileus was unknown.The patient developed an event of a serious ileus.This event was assessed as medically significant.Final diagnosis was ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus.Ileus is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: not reported.
 
Event Description
Ileus.Case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.Study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach.The 73rd annual meeting of the japan esophageal society.2019;unk:135, in the scope of post-marketing sponsored study.Center id: unk; patient id: unknown; country: japan.Study title: unsponsored study involving seprafilm.This case was issued in publication in which 5 other related cases were reported: (b)(4) (cluster).This case involves adult patient who experienced ileus, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm was used in the patient for laparotomy (number of sheets used, unknown).On an unknown date, ileus developed.Outcome of ileus was unknown.The patient developed an event of a serious ileus.This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus.Causality between carboxymethylcellulose and sodium hyaluronate and ileus was not reported by the reporter and reportable by the company based on company causality assessment.Reporter comment: not reported.Additional information was received on 28-jun-2019: no new information was received.Additional information was received on 25-jul-2019: no new information was received.No follow-up is possible.Additional information was received on 25-jul-2019 (follow-up receipt date for follow-up local pv receipt date of 25-jul-2019 was 24-jul-2019) from gqp quality operations, industrial affairs quality information management: added investigation summary (investigation summary # (b)(4), event id: (b)(4)); and added reporter information.Correction to the previous report: corrected causality as reported.Local comments: submission of translation of a literature article to the fda.
 
Event Description
Ileus [ileus].Case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.Study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach.The 73rd annual meeting of the japan esophageal society.2019;unk:135, in the scope of post-marketing sponsored study.Center id: unk; patient id: unknown; country: japan study title: unsponsored study involving seprafilm.This case was issued in publication in which 5 other related cases were reported: (b)(4).This case involves adult patient who experienced ileus, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm was used in the patient for laparotomy (number of sheets used, unknown).On an unknown date, ileus developed.Outcome of ileus was unknown.The patient developed an event of a serious ileus.This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus.Causality between carboxymethylcellulose and sodium hyaluronate and ileus was not reported by the reporter and reportable by the company based on company causality assessment.Reporter comment: not reported.Additional information was received on 28-jun-2019: no new information was received.Additional information was received on 25-jul-2019: no new information was received.No follow-up is possible.Additional information was received on 25-jul-2019 (follow-up receipt date for follow-up local pv receipt date of 25-jul-2019 was 24-jul-2019) from gqp quality operations, industrial affairs quality information management: added investigation summary (investigation summary # (b)(4), event id: 59060); and added reporter information.Correction to the previous report: corrected causality as reported.
 
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Brand Name
SEPRAFILM
Type of Device
MCN
MDR Report Key8748669
MDR Text Key149655539
Report Number1220423-2019-00017
Device Sequence Number1
Product Code MCN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup,Followup
Report Date 08/19/2019
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 Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/01/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received08/01/2019
08/19/2019
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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