MAUDE Adverse Event Report: COVIDIEN SURGIPRO II 4/0 18" BLUE P-12; SINGLE USE SUTURE

Catalog Number SP5682G

Device Problem Unraveled Material (1664)

Patient Problem Wound Dehiscence (1154)

Event Date 06/20/2014

Event Type  Injury  

Event Description

Procedure type: not available.According to the reporter, the surgi-pro knots unravelled and the pt wound site dehisced.Pt had to re-enter operating room within hours in order to re-close surgical site.Pt injury: yes, pt wound dehisced and had to be re-closed in operating room.

Manufacturer Narrative

Tracking number: (b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: SURGIPRO II 4/0 18" BLUE P-12
• Type of Device: SINGLE USE SUTURE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy, qa ; 60 middletown ave; north haven, CT 06473 ; 4014925267
• MDR Report Key: 3964903
• MDR Text Key: 18544111
• Report Number: 9612501-2014-00238
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SP5682G
• Device Lot Number: D2H1094X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention