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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 SXPD2B202
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 06/16/2019
Event Type  Injury  
Manufacturer Narrative
To date a sample has not been returned for evaluation and testing. A lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue. A definitive root cause for the reported events of dehiscence(s) cannot be confirmed with certainty. Wound dehiscence is one of the most common complications of surgical wounds, involving the opening of the surgical incision. There are many causes that can result in the wound opening or sutures failing during or post-operative a procedure such as: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition. The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of suture used for a particular procedure. Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise, heavy lifting, recurrent vomiting, coughing or an improper diet that leads to constipation.
 
Event Description
It was reported by our affiliate that a patient returned to emergency room post operative on (b)(6) 2019 with wound dehiscence. The wound was dressed and the patient was transported to the facility where the total knee procedure was performed on (b)(6) 2019. There the wound was re-closed. No additional information.
 
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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 (Section G)
SURGICAL SPECIALTIES CORPORATION
rd 495 montana indusrial park
aguadilla PR 00605
Manufacturer Contact
ronald giannangelo
247 station drive
suite ne1
westwood, MA 02090
MDR Report Key8776040
MDR Text Key150560304
Report Number3010692967-2019-00021
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,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSXPD2B202
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Distributor Facility Aware Date06/16/2019
Event Location Hospital
Date Report to Manufacturer06/28/2019
Date Manufacturer Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/10/2019 Patient Sequence Number: 1
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