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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX STRAFIX SUTURE MONODERM

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SURGICAL SPECIALTIES CORPORATION STRATAFIX STRAFIX SUTURE MONODERM Back to Search Results
Model Number SXMD1B408
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2019 information was received regarding the re-suturing case. The patient had pre-existing scar tissue that's dented which impacted the stratafix. There was an area of infected tissue removed and cleaned prior to the re-suture. The surgeon stated the prineo was removed too early by the staff, there was moisture which rolled off. The surgeon stated the hospital staff was re-trained. There was insufficient closure leaving dead space. The surgeon stated the staff was re-trained. Since addressing these issues the surgeon reports the patient is doing fine. In addition, the patient was given antibiotics to resolve an infection which cultured & mixed anaerobes & staph aureus & granulicatella adiacens. Patient morbidities included type 2 diabetes, hypertension, hx cancer. 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 lot.
 
Event Description
The initial procedure was on (b)(6) 2018. The patient returned to the surgeon with severe dehiscence as well as an infection. Bilateral wounds were still intact and looked good. The dehiscence looked to go down to fascia muscle. Large areas of the tissue had to be re-sutured.
 
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Brand NameSTRATAFIX
Type of DeviceSTRAFIX SUTURE MONODERM
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 Key8331339
MDR Text Key135881610
Report Number3010692967-2019-00004
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 distributor,foreign,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/01/2005,02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberSXMD1B408
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Distributor Facility Aware Date11/27/2018
Event Location Hospital
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1
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