MAUDE Adverse Event Report: PFIZER, INC. (DEVICE) GELFOAM; SPONGE, STERILE; CLASS III

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

Event verbatim [preferred term] pneumoperitoneum [pneumoperitoneum] , gas within a subcapsular haematoma [intra-abdominal haematoma] , subcapsular fluid collection with an air/fluid [localised intraabdominal fluid collection] , 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 6 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.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, gas within a subcapsular haematoma with absorbable gelatin embolization and a subcapsular fluid collection with an air/fluid level and pneumoperitoneum after proximal embolization was assessed as possibly related to the suspect product, absorbable gelatin (gelfoam).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 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.

• Brand Name: GELFOAM
• Type of Device: SPONGE, STERILE; CLASS III
• Manufacturer (Section D): PFIZER, INC. (DEVICE); 7000 portage road; kalamazoo MI 49001
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 6054997
• MDR Text Key: 58311112
• Report Number: 1810189-2016-00008
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 18-286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention