MAUDE Adverse Event Report: COVIDIEN UNKNOWN SURGIGUT SUTURE; SUTURE, ABSORBABLE, NATURAL

Model Number UNKNOWN - SURGI

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Type  Injury  

Event Description

According to the reporter: after an ophthalmic procedure the patient returned 14 months later to have suture cut out in the office.Additional information has been requested but not yet provided.

• Brand Name: UNKNOWN SURGIGUT SUTURE
• 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 06473 ; 2034925267
• MDR Report Key: 5640273
• MDR Text Key: 44698199
• Report Number: 9612501-2016-00126
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN - SURGI
• Device Catalogue Number: UNKNOWN - SURGI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Date Manufacturer Received: 05/06/2016
• 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): Required Intervention