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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE
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ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that a patient underwent a carotis anastomose procedure on an unknown date and suture was used.It was reported that the patient expired.Additional information was requested.
 
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Brand Name
PROLENE POLYPROPYLENE SUTURE
Type of Device
SUTURE, NONABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5742557
MDR Text Key47956249
Report Number2210968-2016-09934
Device Sequence Number1
Product Code GAW
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K133356
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
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 Received06/02/2016
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) Death; Required Intervention;
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