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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN
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ETHICON INC. SUTURE UNKNOWN Back to Search Results
Device Problem Reaction (1514)
Patient Problems Cellulitis (1768); Reaction (2414); Organ Dehiscence (2502); Treatment with medication(s) (2571)
Event Type  Injury  
Event Description
It was reported that a patient underwent a right open reduction internal fixation distal radius fracture procedure on (b)(6) 2013 and suture was used.The patient experienced pus, redness, superficial wound dehiscence, and cellulitis.The patient was prescribed antibiotics and hibiclens.There was no change since (b)(6) 2013.The patient was to be seen on (b)(6) 2013 for evaluation.
 
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
SUTURE UNKNOWN
Type of Device
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 Key3788834
MDR Text Key4442190
Report Number2210968-2014-05640
Device Sequence Number1
Product Code GAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/11/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2014
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 Received04/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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