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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX STRAFIX PDO

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SURGICAL SPECIALTIES CORPORATION STRATAFIX STRAFIX PDO Back to Search Results
Model Number SXPD2B405
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Organ Dehiscence (2502)
Event Date 03/13/2019
Event Type  Injury  
Manufacturer Narrative
To date the complaint device has not been returned to surgical specialties corporation for root cause analysis. The lot number was not provided which precludes a dhr review from being performed at this time. Without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the report wound dehiscence a definitive root cause cannot be determined at this time.
 
Event Description
It was reported by the sales representative a doctor reported three (3) cases of wound dehiscence one (1) week post-op. The surgeon used stratafix in the subcutaneous and deep tissue layers. Second surgeries were performed. The status of the patients is not known and device sutures are not being returned for evaluation.
 
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Brand NameSTRATAFIX
Type of DeviceSTRAFIX PDO
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
rd. 495 montana industrial pk
aguadilla PR 00605
Manufacturer Contact
ronald giannangelo
247 station drive
suite ne1
westwood, MA 02090
MDR Report Key8455802
MDR Text Key140000341
Report Number3010692967-2019-00010
Device Sequence Number1
Product Code GAB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSXPD2B405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Distributor Facility Aware Date03/13/2019
Event Location No Information
Date Report to Manufacturer03/13/2019
Date Manufacturer Received01/14/2005
Is This a Reprocessed and Reused Single-Use Device? Yes

Patient Treatment Data
Date Received: 03/27/2019 Patient Sequence Number: 1
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