MAUDE Adverse Event Report: COVIDIEN CHROMIC GUT 3/0 36 GS-21; SUTURE

Model Number CG922

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 02/17/2015

Event Type  Injury  

Event Description

Patient had complete skin dehiscence of scrotal incision one week postoperatively.The incision had appeared healthy, intact, and without signs of infection after three days.It seems the suture dissolved too soon.I have never had this problem with ethicon chromic raising my concern that it is not an equivalent product.

Manufacturer Narrative

(b)(4).Initial report sent to fda on 03/20/2015.

• Brand Name: CHROMIC GUT 3/0 36 GS-21
• Type of Device: SUTURE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4619378
• MDR Text Key: 15836446
• Report Number: 9612501-2015-00155
• Device Sequence Number: 1
• Product Code: GCJ
• 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: Physician
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: CG922
• Device Catalogue Number: CG922
• Device Lot Number: D4G0261X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other