MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Skin Irritation (2076); Tissue Damage (2104); Not Applicable (3189)

Event Date 07/17/2018

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.Do you have the operative note from your procedure showing which product code of stratafix suture was used? what is the name of your surgeon and contact information? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact the surgeon for more clinical information to be used for a product quality complaint investigation? if so, please sign and return the attached form and provide your surgeon contact information.

Event Description

It was reported by the patient that she underwent bilateral knee replacement procedure on (b)(6) 2018 and barbed suture was used.It was reported that during the first post surgical dressing change, the incision was red, warm to touch and developed blisters.The patient went to rehab and the redness and warmth continued with no temperature.The surgeon opinion was that the patient did not have an infection.The staples were removed on (b)(6) 2018 and the patient experienced wound dehiscence.The patient was evaluated at another facility and sent to wound care center.Culture performed showed staph and enterococcus.The patient is being evaluated at the wound care center.Additional information has been requested.

• Brand Name: STRATAFIX SYMMETRIC PDS
• 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.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8056461
• MDR Text Key: 126884656
• Report Number: 2210968-2018-77079
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• 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