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

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

Patient Problems Edema (1820); Unspecified Infection (1930); Rash (2033); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Type  Injury  

Event Description

Hemodynamic failure [circulatory collapse], inflammatory red patches on the skin [skin inflammation], erythematous skin rash [erythematous skin rash], oedema [oedema], wound secretion [wound secretion], germ nos found/suspected postoperative infection nos [postoperative infection nos].Case narrative: this case is cross referred to cases (b)(4) (same patient) initial information received on 19-mar-2019 and 25-mar-2019 and was processed with the clock start date of 19-mar-2019 regarding an unsolicited valid serious case received from other health professional via health authorities of (b)(6) under reference (b)(4).This case involves an infant male patient of age below 1 year who experienced circulatory collapse, inflammatory red patches on the skin, wound secretion and germ nos found/ suspected postoperative infection nos, after the use of medical device carboxymethylcellulose, sodium hyaluronate (seprafilm) (latency: unknown) the patient's past medical history included laparatomy which he had underwent twice in the past.The medical treatment(s), vaccination(s) and family history were not provided.On the unknown date, the patient underwent third laparotomy and was implanted with carboxymethylcellulose, sodium hyaluronate (lot -unknown) for adherence prophylaxis after surgery.On the unknown patient, he experienced an erythematous skin rash with inflammatory red patches on the skin, oedema, wound secretion and hemodynamic failure.Also, a germ of unknown type was found (suspected postoperative infection nos).Action taken: unknown.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for circulatory collapse.A product technical complaint was initiated and results were pending for the same.

Event Description

Hemodynamic failure [circulatory collapse].Inflammatory red patches on the skin [skin inflammation].Erythematous skin rash.Skin oedema.Wound secretion.Germ nos found/suspected postoperative infection nos.Case narrative: (b)(4) (same patient).Initial information received on 19-mar-2019 and 25-mar-2019 and was processed with the clock start date of 19-mar-2019 regarding an unsolicited valid serious case received from other health professional via health authorities of france under reference (b)(4).This case involves an infant male patient of age below 1 year who experienced circulatory collapse, inflammatory red patches on the skin, wound secretion and germ nos found/ suspected postoperative infection nos, after the use of medical device carboxymethylcellulose, sodium hyaluronate (seprafilm) (latency: unknown).The patient's past medical history included laparatomy which he had underwent twice in the past.The medical treatment(s), vaccination(s) and family history were not provided.On the unknown date, the patient underwent third laparotomy and was implanted with carboxymethylcellulose, sodium hyaluronate (lot -unknown) for adherence prophylaxis after surgery.On the unknown patient, he experienced an erythematous skin rash with inflammatory red patches on the skin, oedema, wound secretion and hemodynamic failure.Also, a germ of unknown type was found (suspected postoperative infection nos).Action taken: unknown.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for circulatory collapse.A product technical complaint (ptc) was initiated on 27-mar-2019 for seprafilm.Batch number unknown, global ptc number: (b)(4).No product lot number was provided by the reporter; therefore sanofi-genzyme biosurgery quality assurance was unable to perform a specific lot history review/investigation in response to the event.Seprafilm adhesion barrier serves as a temporary bioresorbable barrier separating apposing tissue surfaces.The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repaired process takes place.When applied as directed, seprafilm adhesion barrier could be expected to reduce adhesions within the abdominopelvic cavity.Approximately 24 to 48 hours after placement, the membrane became a hydrated gel that was slowly resorbed within one week.Components were excreted in less than 28 days.All seprafilm lots manufactured by genzyme were released for shipment by quality assurance only after successful completion of quality control certificate of analysis testing and review of all device history records and associated manufacturing process documentation.This lot release procedure provided assurance that all product lots were manufactured under specified process parameters and pass final product and sterility specifications.Product safety metrics were compiled by sanofi global pharmacovigilance and epidemiology and presented to senior management.Any trending signal was discussed during these trending meetings and escalated to the safety governance for adjudication.As a lot history review/investigation was unable to be completed and no trending signal has been identified at this time, no capa was considered necessary however; sanofi-genzyme would continue to monitor and trend these types of events and implement appropriate corrective actions where applicable.Final investigation complete date was 11-apr-2019.No safety issues were indicated in this review.Upon internal review on 03-apr-2019 processed with clock start date 19-mar-2019, analysis of similar incidents added.Based on information previously received on 19-mar-2019, the pt and verbatim of the event of oedema was updated to skin oedema.Additional information was received on 11-apr-2019.Global ptc number and ptc results were added.Text amended accordingly.

Event Description

Hemodynamic failure [circulatory collapse].Inflammatory red patches on the skin [skin inflammation].Erythematous skin rash [erythematous skin rash].Oedema [oedema].Wound secretion [wound secretion.] germ nos found/suspected postoperative infection nos [postoperative infection nos].Case narrative: this case is cross referred to cases (b)(6).Initial information received on 19-mar-2019 and 25-mar-2019 and was processed with the clock start date of 19-mar-2019 regarding an unsolicited valid serious case received from other health professional via health authorities of france under reference (b)(4) this case involves an infant male patient of age below 1 year who experienced circulatory collapse, inflammatory red patches on the skin, wound secretion and germ nos found/ suspected postoperative infection nos, after the use of medical device carboxymethylcellulose, sodium hyaluronate (seprafilm) (latency: unknown) the patient's past medical history included laparatomy which he had underwent twice in the past.The medical treatment(s), vaccination(s) and family history were not provided.On the unknown date, the patient underwent third laparotomy and was implanted with carboxymethylcellulose, sodium hyaluronate (lot -unknown) for adherence prophylaxis after surgery.On the unknown patient, he experienced an erythematous skin rash with inflammatory red patches on the skin, oedema, wound secretion and hemodynamic failure.Also, a germ of unknown type was found (suspected postoperative infection nos).Action taken: unknown.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for circulatory collapse.A product technical complaint was initiated and results were pending for the same.Upon internal review on 03-apr-2019 processed with clock start date 19-mar-2019, analysis of similar incidents added.

Event Description

Hemodynamic failure [circulatory collapse].Inflammatory red patches on the skin [skin inflammation].Erythematous skin rash [erythematous skin rash].Skin oedema [skin oedema].Wound secretion [wound secretion].Germ nos found/suspected postoperative infection nos [postoperative infection nos].Case narrative: this case is cross referred to cases (b)(4).Initial information received on 19-mar-2019 and 25-mar-2019 and was processed with the clock start date of (b)(6) 2019 regarding an unsolicited valid serious case received from other health professional via health authorities of france under reference (b)(4).This case involves an infant male patient of age below 1 year who experienced circulatory collapse, inflammatory red patches on the skin, wound secretion and germ nos found/ suspected postoperative infection nos, after the use of medical device carboxymethylcellulose, sodium hyaluronate (seprafilm) (latency: unknown).The patient's past medical history included laparatomy which he had underwent twice in the past.The medical treatment(s), vaccination(s) and family history were not provided.On the unknown date, the patient underwent third laparotomy and was implanted with carboxymethylcellulose, sodium hyaluronate (lot -unknown) for adherence prophylaxis after surgery.On the unknown patient, he experienced an erythematous skin rash with inflammatory red patches on the skin, oedema, wound secretion and hemodynamic failure.Also, a germ of unknown type was found (suspected postoperative infection nos).Action taken: unknown.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for circulatory collapse.A product technical complaint was initiated and results were pending for the same.Upon internal review on 03-apr-2019 processed with clock start date 19-mar-2019, analysis of similar incidents added.Based on information previously received on 19-mar-2019, the pt and verbatim of the event of oedema was updated to skin oedema.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 8469746
• MDR Text Key: 140491251
• Report Number: 1220423-2019-00006
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2019; 04/24/2019; 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention