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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN CHROMIC GUT 3/0 36 GS-21; SUTURE

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COVIDIEN CHROMIC GUT 3/0 36 GS-21; SUTURE Back to Search Results
Model Number CG922
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 02/17/2015
Event Type  Injury  
Event Description
Patient had complete skin dehiscence of scrotal incision one week postoperatively.The incision had appeared healthy, intact, and without signs of infection after three days.It seems the suture dissolved too soon.I have never had this problem with ethicon chromic raising my concern that it is not an equivalent product.
 
Manufacturer Narrative
(b)(4).Initial report sent to fda on 03/20/2015.
 
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Brand Name
CHROMIC GUT 3/0 36 GS-21
Type of Device
SUTURE
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, CT 06473
2034925267
MDR Report Key4619378
MDR Text Key15836446
Report Number9612501-2015-00155
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 02/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Model NumberCG922
Device Catalogue NumberCG922
Device Lot NumberD4G0261X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/25/2015
Initial Date FDA Received03/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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