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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GUT CHROMIC SUTURE; SUTURE ABSORBABLE
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ETHICON INC. GUT CHROMIC SUTURE; SUTURE ABSORBABLE Back to Search Results
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 a revisionary eye procedure due to wound dehiscence and suture was used.The wound dehisced requiring an additional procedure.A cultured was performed and grew out candida parasolopis.The patient was treated with tobradex ointment.
 
Manufacturer Narrative
B)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
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Brand Name
GUT CHROMIC SUTURE
Type of Device
SUTURE ABSORBABLE
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 Key3683791
MDR Text Key4287897
Report Number2210968-2014-02186
Device Sequence Number1
Product Code GAL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2014
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 Received02/19/2014
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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