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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGIFLO KIT; ABSORBABLE HEMOSTATIC
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SURGIFLO KIT; ABSORBABLE HEMOSTATIC Back to Search Results
Model Number MS0011
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Pain (1994)
Event Type  Injury  
Event Description
The patient underwent a column surgery (elective lumbar spine surgery, decompression and fixation) in (b)(6) 2017 and an absorbable hemostat was used.The patient presented with lumbar pain 48 hours after the procedure.A ct scan was taken, the scan showed a collection that looked like a hematoma.The patient underwent an intervention to remove the hematoma and drain it.Upon opening, during the re-operation, the doctor noticed that it was a collection of serohematic liquid, not a hematoma.This serohematic collection was formed by an inflammatory reaction, which was corroborated by a cytochemical study and the result was 100% inflammatory.During the re-operation, the area was drained.The beginning of lower back pain started on (b)(6) 2016, the surgical intervention was on (b)(6) 2016.The doctor states that the patient was very fat, almost obese.The current status of the patient was reported as good.
 
Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 09/23/2020.This medwatch is not reportable by ethicon, inc.As the importer because this device was not imported into the usa.Therefore, this medwatch report is being voided.
 
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Brand Name
SURGIFLO KIT
Type of Device
ABSORBABLE HEMOSTATIC
MDR Report Key7642719
MDR Text Key112496738
Report Number3008478369-2018-00003
Device Sequence Number1
Product Code LMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMS0011
Device Lot Number247500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/23/2016
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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