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

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.

• 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 Key: 8200341
• MDR Text Key: 131597490
• Report Number: 2210968-2018-78050
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219342
• UDI-Public: 10705031219342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• 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 Number: SXPP1A401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention