• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX MONODERM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SURGICAL SPECIALTIES CORPORATION STRATAFIX MONODERM Back to Search Results
Model Number SXMD1B406
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 04/09/2019
Event Type  Injury  
Manufacturer Narrative
To date no samples have been received by surgical specialties corporation for root cause and failure analysis. Without reviewing and testing the actual device or receiving details of what was observed upon return of the patient and/or what type of intervention was required a definitive root cause cannot be determined at this time. A review of the device history records for the finished good lots, did not identify any quality issues during the incoming, manufacturing, in-process or final inspection processes. There have been no lots released for distribution which failed to meet any of the product specifications or current acceptance criteria. When and if additional information is received a follow-up report will be filed. There were no other complaints received of any kind for the reported lot number.
 
Event Description
It was reported the patient had laparoscopic right hernioplasty on (b)(6) 2019. Patient was discharged after 4 days. On (b)(6) the patient was sick and in pain. Ct report indicated that volvulus was observed. It was found end of the suture adhered jejunal mesentery and physician figured it out. The patient is doing better and was discharged on (b)(6) 2019.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8607776
MDR Text Key144969433
Report Number3010692967-2019-00016
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 01/01/2005,05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSXMD1B406
Device Lot NumberMDVR760
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Distributor Facility Aware Date04/09/2019
Device Age2 YR
Event Location No Information
Date Report to Manufacturer04/29/2019
Date Manufacturer Received01/14/2005
Is This a Reprocessed and Reused Single-Use Device? No

-
-