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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE; SUTURE, SURGICAL, ABSORABLE
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ETHICON STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE; SUTURE, SURGICAL, ABSORABLE Back to Search Results
Catalog Number SXPD2B202
Device Problem Defective Device (2588)
Patient Problem Wound Dehiscence (1154)
Event Date 04/05/2016
Event Type  Injury  
Event Description
Dr.Brought patient to operating room for posterior cervical wound dehiscence.Patient had his original surgery approximately two weeks prior to dehiscence.Dr.Stated that they used four stratafix sutures to close the initial incision.The patient arrived to the office with wound dehiscence and was admitted to the hospital to repair the wound.A follow up needed to be done because doctors believe there is a defect with the new stratafix suture the hospital recently began to use.This product was brought in to replace the quill suture.
 
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Brand Name
STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE
Type of Device
SUTURE, SURGICAL, ABSORABLE
Manufacturer (Section D)
ETHICON
route 22 west
po box 151
somerville NJ 08876
MDR Report Key5652279
MDR Text Key45131951
Report Number5652279
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 Other
Type of Report Initial
Report Date 04/28/2016,04/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date11/30/2020
Device Catalogue NumberSXPD2B202
Device Lot NumberMDQX980
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/28/2016
Event Location Hospital
Date Report to Manufacturer04/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER DEVICES
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age65 YR
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