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| Device Problem
Insufficient Information (3190)
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| Patient Problem
Hematoma (1884)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] gas within a subcapsular haematoma [intra-abdominal haematoma] , subcapsular fluid collection with an air/fluid level [localised intraabdominal fluid collection] , pneumoperitoneum [pneumoperitoneum] , indication of proximal embolization [product use issue] ,.Case narrative:this is a literature report from j vasc interv radiol, 2001, vol 12, pgs 209-214, entitled "ct findings after embolization for blunt splenic trauma".Full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports.A patient of unspecified age, ethnicity and gender started to receive absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history and concomitant medications were not reported.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin and the outcome of the events was unknown.(b)(4) is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities., comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.The case will be reassessed should additional information become available.The impact of this report on the benefit/risk profile of the (b)(4) product is evaluated as part of (b)(4) procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Event Description
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Event verbatim [preferred term] gas within a subcapsular haematoma [intra-abdominal haematoma] , subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection] , pneumoperitoneum [pneumoperitoneum] , indication of proximal embolization [product use in unapproved indication] ,.Case narrative:this is a literature report from j vasc interv radiol, 2001, vol 12, pgs 209-214, entitled "ct findings after embolization for blunt splenic trauma".Full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports for a (b)(6) year old female patient.A patient of unspecified age, ethnicity and gender started to receive absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury and concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, new york, ny) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin and the outcome of the events was unknown.The subcapsular collection was drained.The outcome of all of the events was unknown.Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Follow-up (21dec2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled ct findings after embolization for blunt splenic trauma.This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities., comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.No change in previous assessment based on additional information received.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Event Description
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Gas within a subcapsular haematoma [intra-abdominal haematoma] subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection] pneumoperitoneum [pneumoperitoneum] indication of proximal embolization [product use in unapproved indication] case description: this is a literature report from j vasc interv radiol, 2001, vol 12, pgs 209-214, entitled "ct findings after embolization for blunt splenic trauma".Full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports for a (b)(6) year old female patient.A patient of unspecified age, ethnicity and gender started to receive absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury and concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, (b)(4)) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin and the outcome of the events was unknown.The subcapsular collection was drained.The outcome of all of the events was unknown.Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Follow-up (21dec2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled ct findings after embolization for blunt splenic trauma.This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.No change in previous assessment based on additional information received.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Event verbatim [preferred term] gas within a subcapsular haematoma [intra-abdominal haematoma], subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection], pneumoperitoneum [pneumoperitoneum], indication of proximal embolization [product use in unapproved indication] ,.Case narrative:this is a literature report from j vasc interv radiol, 2001, vol 12, pgs 209-214, entitled "ct findings after embolization for blunt splenic trauma".Full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports for a (b)(6) female patient.A patient of unspecified age, ethnicity and gender started to receive absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury and concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, new york, ny) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin and the outcome of the events was unknown.The subcapsular collection was drained.The outcome of all of the events was unknown.Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Follow-up (21dec2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled ct findings after embolization for blunt splenic trauma.This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Amendment: this follow-up is being submitted to amend previously reported information: age and gender added amendment: this follow-up is being submitted to amend previously reported information: additional information button unchecked and correction checked., comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.No change in previous assessment based on additional information received.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Event Description
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Event verbatim [preferred term] gas within a subcapsular haematoma [intra-abdominal haematoma] , subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection] , pneumoperitoneum [pneumoperitoneum] , indication of proximal embolization [product use in unapproved indication] ,.Case narrative:this is a literature report from j vasc interv radiol, 2001, vol 12, pgs 209-214, entitled "ct findings after embolization for blunt splenic trauma".Full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports for a (b)(6) female patient.A patient of unspecified age, ethnicity and gender started to receive absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury and concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, new york, ny) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin and the outcome of the events was unknown.The subcapsular collection was drained.The outcome of all of the events was unknown.Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Follow-up (21dec2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled ct findings after embolization for blunt splenic trauma.This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Amendment: this follow-up is being submitted to amend previously reported information: age and gender added amendment: this follow-up is being submitted to amend previously reported information: additional information button unchecked and correction checked., comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.No change in previous assessment based on additional information received.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Event Description
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Event verbatim [preferred term] gas within a subcapsular haematoma [intra-abdominal haematoma] , subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection] , pneumoperitoneum [pneumoperitoneum] , indication of proximal embolization [product use in unapproved indication] , case narrative:this is a literature report from j.Vasc interv radiol, 2001, vol 12; pgs 209-214, entitled "ct findings after embolization for blunt splenic trauma." the full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports and refers to a 36-year-old female patient.A 36-year-old female patient of unspecified ethnicity started treatment with absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury.Concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, new york, ny) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin was unknown.The subcapsular collection was drained.The outcomes of the events was unknown.Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Follow-up (b)(6) 2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled, 'ct findings after embolization for blunt splenic trauma.' this is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Amendment: this follow-up is being submitted to amend previously reported information: age and gender added amendment: this follow-up is being submitted to amend previously reported information: additional information button unchecked and correction checked.Follow-up (b)(6) 2019): this is a follow up report received from product complaint group.Pcom number: (b)(4) and pcom number: (b)(4).(b)(4).: may be associated for intra-abdominal fluid collection., comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.The follow-up information received does not alter the previous company clinical evaluation.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Event Description
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Event verbatim [preferred term] indication of proximal embolization [product use in unapproved indication] , indication of proximal embolization [off label use] , gas within a subcapsular haematoma [intra-abdominal haematoma] , subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection] , pneumoperitoneum [pneumoperitoneum] ,.Case narrative:this is a literature report from j.Vasc interv radiol, 2001, vol 12; pp 209-214, entitled "ct findings after embolization for blunt splenic trauma." the full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports and refers to a 36-year-old female patient.A 36-year-old female patient of unspecified ethnicity started treatment with absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury.Concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, new york, ny) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin was unknown.The subcapsular collection was drained.The outcomes of the events was unknown.Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Follow-up (b)(6) 2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled, 'ct findings after embolization for blunt splenic trauma.' this is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Amendment: this follow-up is being submitted to amend previously reported information: age and gender added.Amendment: this follow-up is being submitted to amend previously reported information: additional information button unchecked and correction checked.Follow-up (b)(6) 2019): this is a follow up report received from product complaint group.Pcom number: 2019-04-0028470-us and pcom number: 2019-04-0028495-us.Aer# 2016477253: may be associated for intra-abdominal fluid collection.Amendment: this follow-up report is being submitted to amend previously reported information: pcom number: 2019-04-0028470-us was not specific for this case, and therefore, has been removed.Follow-up (11jun2019): this is a follow up report based on information received from quality operations, product complaints.Pre complaint number: pcom-2016-0079649-us.Complaint number: 2016-10-0061713-us.Priority: normal.Product desc: gelfoam sterile sponge size 50 x 4.Product country: us.Sap/ unique identifier: 0009-0323-01.Lot number: unknown.Lot number unknown reason: not provided in correspondence / email communication.Udi: 10300090323018.Sample status: not available.Scope: all gelfoam sponge batches produced within the 36 months prior to the receipt of the reported complaint were queried within pcom, and all complaints found were examined against the reported complaint narrative and complaint classification.Three previously completed complaints with known batch numbers were determined to be in scope: 2014-10-0052810-us (h94291), 2015-11-0060940-us (l85450) and 2016-02-0009667-us (l63414) returned product examination: (site name redacted) did not receive a return sample, or photographs, for evaluation.Reference sample examination: complete - acceptable.Manufacturing and packaging records: complete - acceptable.Qo batch idstory report: complete - acceptable.As the batch number for the reported complaint is unknown, a review of the batch history for the complaint could not be performed.Medical device trend analysis: complete - acceptable root cause: pfizer (site name redacted) could not conclusively determine a root cause for the reported defect to be related to the (site name redacted) production process.Gelfoam sterile sponge has hemostatic properties.While its mode of action is not fully understood, its effect appears to be more physical than the result of altering the blood clotting mechanism.Therefore, analysis of the water absorption properties of each finished gelfoam batch indicates that the device functions properly.Review of the aprr reports and evaluation of trends, as well as previously investigated complaint reports, indicated that all gelfoam batches relevant to this investigation had met established requirements at the time of release.Corrective action: all reviewed records, investigation reports, and in-process controls were acceptable, and have met the established requirements.The retained reference samples examined as a part of previous investigations were found to be acceptable with no quality defects observed.As a result of a stability oos analytical result for the gelfoam compressed sponge form, a pma supplement was submitted to the fda and the stability limits were changed from nlt 35x its weight in water to ''report results''.This was deemed acceptable for continued distribution.Therefore, no corrective actions were identified as a direct result of this complaint investigation.Quality of lot: acceptable.The details of the reported complaint have been forwarded to pfizer safety for evaluation of regulatory reportability due to the worst case severity level of s5 for the reported defect as determined from a review of the device risk file for the product.Based upon the results of this investigation, (site name redacted) concludes that the quality of the product on the market remains acceptable.Conclusion: the review of all records and reports within scope of this investigation demonstrated the acceptability of the product over the timefrarne within scope.As the reported defect is a product malfunction, the complaint has been escalated to pfizer safety for evaluation of regulatory reportability.Further action by pfizer (site name redacted) is not required.Follow-up (b)(6) 2019): this is a follow up report received from product complaint group.A complaint has been received by pfizer (site name redacted) with no indication of a malfunction.Worst case severity is unknown, and therefore requires escalation to pfizer us.Safety.Impact to the device: possible adverse event.Pcom number: 2019-06-0039219-us; hazardous situation: uknown; hazard number: unknown; p2 value: unknown; previous mdr: none.The complaint is to be evaluated for mdr.Correction to notification below: mdr issued previously: 2016477250, 2016477251, 2016477252, 2016477253, 2016477222.Company clinical evaluation comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.The follow-up information received does not alter the previous company clinical evaluation.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate., comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.The follow-up information received does not alter the previous company clinical evaluation.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Event Description
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Gas within a subcapsular haematoma [intra-abdominal haematoma], subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection], pneumoperitoneum [pneumoperitoneum], indication of proximal embolization [product use in unapproved indication].Case narrative: this is a literature report from j.Vasc interv radiol, 2001, vol 12; pgs 209-214, entitled "ct findings after embolization for blunt splenic trauma." the full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports and refers to a 36-year-old female patient.A 36-year-old female patient of unspecified ethnicity started treatment with absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury.Concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, new york, ny) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin was unknown.The subcapsular collection was drained.The outcomes of the events was unknown.Pfizer is the marketing authorization holder of absorbable gelatin in the reporter's country.This may be a duplicate report if another marketing authorization holder of absorbable gelatin has submitted the same report to the regulatory authorities.Follow-up (21dec2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled, 'ct findings after embolization for blunt splenic trauma.' this is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Amendment: this follow-up is being submitted to amend previously reported information: age and gender added.Amendment: this follow-up is being submitted to amend previously reported information: additional information button unchecked and correction checked.Follow-up (29apr2019): this is a follow up report received from product complaint group.Pcom number: (b)(4).Aer#: (b)(4): may be associated for intra-abdominal fluid collection.Amendment: this follow-up report is being submitted to amend previously reported information: pcom number: (b)(4) was not specific for this case, and therefore, has been removed.Comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.The follow-up information received does not alter the previous company clinical evaluation.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Event Description
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Event verbatim [preferred term] indication of proximal embolization [product use in unapproved indication] , indication of proximal embolization [off label use] , pneumoperitoneum [pneumoperitoneum] , gas within a subcapsular haematoma [intra-abdominal haematoma] , subcapsular fluid collection with an air/fluid level [intra-abdominal fluid collection] ,.Case narrative:this is a literature report from j.Vasc interv radiol, 2001, vol 12; pp 209-214, entitled "ct findings after embolization for blunt splenic trauma." the full publication has been requested.This reporter reported 6 reports; this is the 5 of 6 reports and refers to a 36-year-old female patient.A 36-year-old female patient of unspecified ethnicity started treatment with absorbable gelatin (gelfoam), intravascular, from an unspecified date, at an unspecified dose, for proximal embolization after blunt splenic injury.Medical history included blunt splenic injury.Concomitant medications included single dose of oral contrast material (5 g of diatrizoate sodium powder dissolved in 300 ml of water; hypaque; nycomed, new york, ny) and 150 ml of intravenous iohexol (omnipaque 240; nycomed) before scanning.The patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.The action taken with absorbable gelatin was unknown.The subcapsular collection was drained.The outcomes of the events were unknown.Follow-up (21dec2017): this is a literature report from the journal of vascular and interventional radiology, 2001, vol 12(2); pp 209-214 entitled, 'ct findings after embolization for blunt splenic trauma.' this is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.New info included patient data (medical history, concomitant drugs) and event data (treatment and testing).Amendment: this follow-up is being submitted to amend previously reported information: age and gender added.Amendment: this follow-up is being submitted to amend previously reported information: additional information button unchecked and correction checked.Follow-up (29apr2019): this is a follow up report received from product complaint group.Pcom number: (b)(4) and pcom number: (b)(4).Aer# 2016477253: may be associated for intra-abdominal fluid collection.Amendment: this follow-up report is being submitted to amend previously reported information: pcom number: (b)(4) was not specific for this case, and therefore, has been removed.Follow-up (11jun2019): this is a follow up report based on information received from quality operations, product complaints.Pre complaint number: (b)(4).Complaint number: (b)(4).Priority: normal.Product desc: gelfoam sterile sponge size 50 x 4.Product country: us.Sap/ unique identifier: (b)(4).Lot number: unknown.Lot number unknown reason: not provided in correspondence / email communication.Udi: (b)(4).Sample status: not available.Scope: all gelfoam sponge batches produced within the 36 months prior to the receipt of the reported complaint were queried within pcom, and all complaints found were examined against the reported complaint narrative and complaint classification.Three previously completed complaints with known batch numbers were determined to be in scope: 2014-10-0052810-us (h94291), 2015-11-0060940-us (l85450) and 2016-02-0009667-us (l63414) returned product examination: (site name redacted) did not receive a return sample, or photographs, for evaluation.Reference sample examination: complete - acceptable.Manufacturing and packaging records: complete - acceptable.Qo batch idstory report: complete - acceptable.As the batch number for the reported complaint is unknown, a review of the batch history for the complaint could not be performed.Medical device trend analysis: complete - acceptable root cause: pfizer (site name redacted) could not conclusively determine a root cause for the reported defect to be related to the (site name redacted) production process.Gelfoam sterile sponge has hemostatic properties.While its mode of action is not fully understood, its effect appears to be more physical than the result of altering the blood clotting mechanism.Therefore, analysis of the water absorption properties of each finished gelfoam batch indicates that the device functions properly.Review of the aprr reports and evaluation of trends, as well as previously investigated complaint reports, indicated that all gelfoam batches relevant to this investigation had met established requirements at the time of release.Corrective action: all reviewed records, investigation reports, and in-process controls were acceptable, and have met the established requirements.The retained reference samples examined as a part of previous investigations were found to be acceptable with no quality defects observed.As a result of a stability oos analytical result for the gelfoam compressed sponge form, a pma supplement was submitted to the fda and the stability limits were changed from nlt 35x its weight in water to ''report results''.This was deemed acceptable for continued distribution.Therefore, no corrective actions were identified as a direct result of this complaint investigation.Quality of lot: acceptable.The details of the reported complaint have been forwarded to pfizer safety for evaluation of regulatory reportability due to the worst case severity level of s5 for the reported defect as determined from a review of the device risk file for the product.Based upon the results of this investigation, (site name redacted) concludes that the quality of the product on the market remains acceptable.Conclusion: the review of all records and reports within scope of this investigation demonstrated the acceptability of the product over the timefrarne within scope.As the reported defect is a product malfunction, the complaint has been escalated to pfizer safety for evaluation of regulatory reportability.Further action by pfizer (site name redacted) is not required.Follow-up (12jun2019): this is a follow up report received from product complaint group.A complaint has been received by pfizer (site name redacted) with no indication of a malfunction.Worst case severity is unknown, and therefore requires escalation to pfizer us.Safety.Impact to the device: possible adverse event.Pcom number: 2019-06-0039219-us; hazardous situation: uknown; hazard number: unknown; p2 value: unknown; previous mdr: none.The complaint is to be evaluated for mdr.Correction to notification below: mdr issued previously: 2016477250, 2016477251, 2016477252, 2016477253, 2016477222.Follow-up (08feb2020): this is a follow up report based on information received from products quality complaints group.Conclusion: the review of all records and reports within scope of this investigation demonstrated the acceptability of the product over the timeframe within scope.No product quality issues were observed.The complaint has been escalated to safety for evaluation of regulatory reportability.The details of the reported complaint have been sent to the mdcp team for review.Further action by pfizer manufacturing site is not required.Company clinical evaluation comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.It was noted that the subcapsular collection was drained.No product quality issues were observed.The follow-up information received does not alter the previous company clinical evaluation.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate., comment: based on the available information, the patient developed gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization.However, of note the product is not indicated for arterial embolization.It was noted that the subcapsular collection was drained.No product quality issues were observed.The follow-up information received does not alter the previous company clinical evaluation.The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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Manufacturer Narrative
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(b)(6)2020 : conclusion: the review of all records and reports within scope of this investigation demonstrated the acceptability of the product over the timeframe within scope.No product quality issues were observed.The complaint has been escalated to safety for evaluation of regulatory reportability.The details of the reported complaint have been sent to the mdcp team for review.Further action by pfizer manufacturing site is not required.11jun2019: this is a follow up report based on information received from quality operations, product complaints.Pre complaint number: (b)(4).Complaint number:(b)(4).Priority: normal.Product desc: gelfoam sterile sponge size 50 x 4.Product country: us.Sap/ unique identifier: 0009-0323-01.Lot number: unknown.Lot number unknown reason: not provided in correspondence / email communication.Udi: (b)(4).Sample status: not available.Scope: all gelfoam sponge batches produced within the 36 months prior to the receipt of the reported complaint were queried within pcom, and all complaints found were examined against the reported complaint narrative and complaint classification.Three previously completed complaints with known batch numbers were determined to be in scope: 2014-10-0052810-us (h94291), 2015-11-0060940-us (l85450) and 2016-02-0009667-us (l63414) returned product examination: (site name redacted) did not receive a return sample, or photographs, for evaluation.Reference sample examination: complete - acceptable.Manufacturing and packaging records: complete - acceptable.Qo batch idstory report: complete - acceptable.As the batch number for the reported complaint is unknown, a review of the batch history for the complaint could not be performed.Medical device trend analysis: complete - acceptable root cause: pfizer (site name redacted) could not conclusively determine a root cause for the reported defect to be related to the (site name redacted) production process.Gelf.
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Search Alerts/Recalls
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