MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN SUTURE PRODUCT

Device Problems Break (1069); Degraded (1153); Unraveled Material (1664)

Patient Problem Wound Dehiscence (1154)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information has not been provided as to the product model number, lot suture type, 510k or procode and product return is not expected.It is currently unknown as to the treatment that was given to the patient in response to the conditions discovered so it is unknown if the sutures were removed or if reoperation was required beyond that which was scheduled for the staged spinal surgery.Additional information has been requested of the account but not yet received.Should additional information be provided the report will be updated.

Event Description

According to the reporter; patient had a planned staged spine surgery.First stage was on (b)(6) 2016, and the wound was closed in standard fashion using covidien suture that is available in the or.5 days later, the patient was taken back to the operating room for the second stage of the procedure, and was found to have wound dehiscence at the superior portion of his wound.The suture that had been placed in the fascia in this region had dissolved and unraveled at multiple sites.

• Brand Name: UNKNOWN SUTURE PRODUCT
• Type of Device: SUTURE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5763512
• MDR Text Key: 48619303
• Report Number: 1219930-2016-00670
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other