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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX MONODERM

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SURGICAL SPECIALTIES CORPORATION STRATAFIX MONODERM Back to Search Results
Model Number SXMD1B105
Device Problem Insufficient Information (3190)
Patient Problem Wound Dehiscence (1154)
Event Type  Injury  
Manufacturer Narrative
To date the samples have not been received by surgical specialties corporation for root cause and failure analysis. To date 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 without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, post-operative instructions or events that may have occurred and/or contributed to the reports of wound dehiscence, a definitive root cause cannot be determined at this time. When and if additional information is received a follow-up report will be filed.
 
Event Description
Out affiliate is reporting a patient returned to the surgeon with a case of dehiscence.
 
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Brand NameSTRATAFIX
Type of DeviceMONODERM
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 Key8394841
MDR Text Key137973796
Report Number3010692967-2019-00009
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,Followup
Report Date 01/01/2005,06/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Model NumberSXMD1B105
Device Lot NumberMDVT390,MDVZ020
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
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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