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

Lot Number UNKNOWN

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  

Manufacturer Narrative

Sanofi company comment dated 19-mar-2019: this case concerns a patient who was seprafilm and reported to have circulatory collapse.Based upon the information, the causal role of product cannot be denied with the occurrence of events.However, lack of information regarding concomitant medications, current clinical presentation, relevant medical history, underlying condition and other risk factors precludes the complete medical case assessment.

Event Description

Circulatory collapse [circulatory collapse], inflammatory red patches on the skin [skin inflammation], erythematous skin rash [erythematous skin rash], edema [edema], 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 once in the past.The medical treatment(s), vaccination(s) and family history were not provided.On the unknown date, the patient underwent second 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.

Manufacturer Narrative

Based on the available information the causal role of seprafilm cannot be excluded with the occurrence of the reported circulatory collapse.Further information on the indication of the surgery, concomitant medications, origin and nature of postoperative infection, other risk factors and corrective treatments dimmed necessary for a proper medical assessment.

Event Description

Circulatory collapse [circulatory collapse].Inflammatory red patches on the skin [skin inflammation].Erythematous skin rash [erythematous skin rash].Edema [edema].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 once in the past.The medical treatment(s), vaccination(s) and family history were not provided.On the unknown date, the patient underwent second 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

Circulatory collapse [circulatory collapse].Inflammatory red patches on the skin [skin inflammation].Erythematous skin rash [erythematous skin rash].Edema [skin edema].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 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 once in the past.The medical treatment(s), vaccination(s) and family history were not provided.On the unknown date, the patient underwent second 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 (b)(6) 2019 for seprafilm.Batch number: unknow; global ptc number: (b)(4).No product lot number was provided by reporter; therefore sanofi-genzyme biosurgery quality assurance was unable to perform a specific lot history review/investigation in response to this 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 repair process takes place.When applied as directed, seprafilm adhesion barrier can be expected to reduce adhesions within the abdominopelvic cavity.Approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week.Components are excreted in less than 28 days.All seprafilm lots manufactured by genzyme are 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 provides assurance that all product lots are manufactured under specified process parameters and pass final product and sterility specifications.Product safety metrics are 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.Sanofi-genzyme will continue to monitor and trend these types of events and implement appropriate corrective actions where applicable.If lot number for this event is reported at later date, lot investigation will be performed by sanofi-genzyme biosurgery quality assurance at that time.Upon internal review on (b)(6) 2019 processed with clock start date (b)(6) 2019, analysis of similar incidents added.Additional information was received on 11-apr-2019.Global ptc number and its results were added.Text amended accordingly.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 8469785
• MDR Text Key: 140492581
• Report Number: 1220423-2019-00005
• 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
• Report Date: 04/18/2019

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