Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 STRATAFIX SPIRAL; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  • 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 STRATAFIX SPIRAL; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE Back to Search Results
Model Number SXPD2B405
Device Problem Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 01/31/2018
Event Type  malfunction  
Event Description
Barbs on suture are smaller than before but opening other packages of same suture barbs are of inconsistent lengths.Basically - inconsistent suture quality of three different lot numbers evaluated (other lots are mdds230 and aab5721).
 
Event Description
Barbs on suture are smaller than before but opening other packages of same suture barbs are of inconsistent lengths.Basically - inconsistent suture quality of three different lot numbers evaluated (other lots are mdds230 and aab5721).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRATAFIX SPIRAL
Type of Device
SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Manufacturer (Section D)
SURGICAL SPECIALTIES
247 station drive ne1
westwood MA 02090
MDR Report Key7288394
MDR Text Key100662813
Report Number7288394
Device Sequence Number1
Product Code NEW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/14/2018,02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date06/30/2022
Device Model NumberSXPD2B405
Device Catalogue NumberSXPD2B405
Device Lot NumberAABP642
Other Device ID NumberSXPD2B405
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2018
Event Location Hospital
Date Report to Manufacturer02/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexUnknown
-
-