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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

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ETHICON INC. SFX SYM PDS+ VIO 18IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Catalog Number SXPP1A401
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 01/01/2018
Event Type  Injury  
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.What was the date of the initial procedure? what tissue was the stratafix symmetric suture used on? what post op date was the infection diagnosed? what layer of tissue was the infection noted? were any cultures taken of the wound? what were the results? can you identify the lot number? what was the date of the second procedure? what is the surgeons opinion of the relationship of the stratafix symmetric suture and the infection? can you describe the appearance of the suture during the second procedure? what are the patient age, gender, weight, other medical conditions? what is the current condition of the patient?.
 
Event Description
It was reported that the patient underwent total knee replacement on an unknown date and barbed suture was used.Following the procedure, the patient experienced a wound infection.The patient received a wash out and antibiotics.Additional information has been requested.
 
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Brand Name
SFX SYM PDS+ VIO 18IN 0 S/A CT-1
Type of Device
SUTURE, SURGICAL, ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-JUAREZ
avenida de las torres 7125
col salvacar
coidad juarez 32604
MX   32604
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8200341
MDR Text Key131597490
Report Number2210968-2018-78050
Device Sequence Number1
Product Code NEW
UDI-Device Identifier10705031219342
UDI-Public10705031219342
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 12/05/2018
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? No
Device Operator Health Professional
Device Catalogue NumberSXPP1A401
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2018
Initial Date FDA Received12/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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