MAUDE Adverse Event Report: COVIDIEN CHROMIC GUT SIZE 7-0 USP (0.7 METRIC), 18 INCHES (; SURGICAL ABSORBABLE GUT SUTURE

Model Number G2797K

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Procedure type : ophthalmology (b)(6) was opened to capture the instance of multiple complaints reported in the description under (b)(4) provided below.According to the reporter: covidien suture does not dissolve in the eye as quickly as ethicon.The dr.Had several patients who came back with suture knots that did not dissolve as before.The knots are lasting for a couple of months and patients are complaining and coming in to have them removed.The current status of the patients is unknown.It is reported that there was no tissue loss or damage.It is both reported that another suture was applied and that no reoperation was needed and follow up for additional information has been sent out but as of yet no additional information has been provided.

Manufacturer Narrative

(b)(4).

• Brand Name: CHROMIC GUT SIZE 7-0 USP (0.7 METRIC), 18 INCHES (
• Type of Device: SURGICAL ABSORBABLE GUT 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: 4904540
• MDR Text Key: 17205140
• Report Number: 9612501-2015-00393
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K885018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G2797K
• Device Catalogue Number: G2797K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other