MAUDE Adverse Event Report: ETHICON INC. GUT CHROMIC SUTURE

Device Problem Reaction (1514)

Patient Problems Wound Dehiscence (1154); Surgical procedure (2357); Reaction (2414); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent eyelid surgery approximately 4 months ago to remove basil cell carcinoma.Suture was used to close the skin.The wound dehisced and the patient required a second surgery.A cultured was performed and grew out candida parasolopis.The patient was treated with tobradex ointment.

Event Description

It was reported that a patient underwent eyelid surgery approximately 4 months ago to remove basil cell carcinoma.Suture was used to close the skin.The wound dehisced and the patient required a second surgery.A culture was performed and grew out candida parasolopis.The patient was treated with tobradex ointment.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: GUT CHROMIC SUTURE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3683653
• MDR Text Key: 4241066
• Report Number: 2210968-2014-02178
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention