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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MONOCRYL POLIGLECAPRONE 25 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MONOCRYL POLIGLECAPRONE 25 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Wound Dehiscence (1154); Therapy/non-surgical treatment, additional (2519)
Event Type  Injury  
Event Description
It was reported that the patient underwent cabg procedure approximately one month ago and suture was used.Following the procedure, the patient experienced wound dehiscence and a wound vac was placed on the patient¿s wound.Additional information has been requested.
 
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.(b)(4).
 
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Brand Name
MONOCRYL POLIGLECAPRONE 25 SUTURE
Type of Device
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
mary szaro
9082183464
MDR Report Key4862551
MDR Text Key21066265
Report Number2210968-2015-07390
Device Sequence Number1
Product Code GAN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960653
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2015
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 Received06/02/2015
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 Number1
Patient Outcome(s) Required Intervention;
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