MAUDE Adverse Event Report: COVIDIEN CHROMIC GUT 2/0 30 V-20 107Q; SUTURE, ABSORBABLE, NATURAL

Model Number GG123

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: patient had a vasectomy.Details could not be provided at the time of the call with the account but the patient had to return to the office to get the suture removed.It was estimated that the original procedure had to have taken place within a few weeks of the removal.The accounts expectation of the device and what is told to patients is that the suture is dissolved in 7 to 10 days.

• Brand Name: CHROMIC GUT 2/0 30 V-20 107Q
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• 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: 5628095
• MDR Text Key: 44296486
• Report Number: 9612501-2016-00119
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 20884521054902
• UDI-Public: (01)20884521054902
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2016

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: 04/30/2015
• Device Model Number: GG123
• Device Catalogue Number: GG123
• Device Lot Number: D5D1830GX
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention