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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX PDO

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SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX PDO Back to Search Results
Model Number UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Unspecified Infection (1930); Discharge (2225); Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative
The item number, and lot number were reported as "unknown. No samples were returned for review and/or testing. Without receiving pertinent item and lot code details relevant portions of the device history records could not be reviewed. The narrative received by the reporter and end user indicate that the post-operative events and infection may have resulted due to a reaction to the proceed mesh material. The is no evidence of any ethicon product deficiency, therefore, none of the events can be directly related to ethicon/stratifix products.
 
Event Description
The 2-0 and size 0 statafix devices in conjunction with 20x20 and 20x10 proceed mesh material were utilized for 106 davinci robotic procedures to repair ventral and other types of hernias. There were reported cases of post-operative surgical site infection, drainage, bowel obstruction, and other events that required intervention. It was noted that the proceed mesh may have been the cause for the post-operative events. The was no evidence of any ethicon product deficiency, therefore, none of the events can be directly related to ethicon product.
 
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Brand NameSTRATAFIX
Type of DeviceSTRATAFIX PDO
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
Manufacturer (Section G)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000 #24702b
ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key7632751
MDR Text Key112142108
Report Number3010692967-2018-00010
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
PMA/PMN Number
K051609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/21/2018
Event Location Hospital
Date Manufacturer Received05/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2018 Patient Sequence Number: 1
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