MAUDE Adverse Event Report: ETHICON INC. STRATAFIX UNKNOWN; SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Skin Irritation (2076)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following additional information was requested and obtained: what is the initial procedure date? (b)(6) 2019.What date did the reaction occur on? ~3 weeks post initial procedure 4 week check ¿ had been like it for a couple of weeks.What does the reaction look like and how large of an area does the reaction cover? full leg- reddened around incision.Do you have any pictures of the reaction? was the cortisone treatment oral or topical? steroids oral given.Was there any additional medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.No.What is the most current patient status? rash cleared ¿ weeks later.Can you identify the product code and lot number of the product that was used? no.As it was a tkr, was the product applied while knee was extended or flexed? flexed.What prep was used prior to, during or after prineo use? betadine (povidone-iodine), or chlorhexidine? preop ¿ alcoholic betadine/prior to skin closure 0.05% blue chlorhexidine was a protective, dry wound dressing such as gauze applied and was it applied only after the liquid topical skin adhesive has completely polymerized and the dermabond¿ prineo¿ is no longer tacky to the touch? yes, once dry honeycomb opsite dressing applied.Was the application site cleansed thoroughly with saline or isopropyl alcohol to remove any remaining blood, fluids, or topical medications/anaesthetics, including skin preps, and then patted dry? blue cholrhex used for skin edge clean prior to skin closure.Hypersensitivity to cyanoacrylate, formaldehyde, or pressure sensitive adhesive and using relatable terms such as hypersensitive to bandages, tape, hobbyist glue, cosmetic eyelashes or artificial nails or any recent exposure? postoperatively stated ?allergy to opsite ¿ not known preop.Were any patch or sensitivity tests performed prior to the procedure? na.Patient¿s demographics: initials / id; age or date of birth; bmi; gender ¿ sh/female ¿ no.Other info available: patient pre-existing medical conditions (ie.Allergies, history of reactions) - none known preop ¿ although she stated post op ? opsite allergy.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Who applies the product, the surgeon? assistant.The following questions have been asked and no response to date: was any issue noted with the stratafix suture? product code of stratafix? lot number of stratafix? attempts have been made to obtain additional information.To date the device has not been returned and additional information has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent a total knee replacement procedure on (b)(6) 2019 and barbed suture was used.Patient returned 4 weeks post operatively with a skin reaction, inflammation, redness and allergy at operative site.Treated with oral steroids.Lot number is unknown.Additional information was requested.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was received that there were no issues with this device in the patient event.Therefore, this medwatch report 2210968-2019-84850 is void.

• Brand Name: STRATAFIX UNKNOWN
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8840490
• MDR Text Key: 152616125
• Report Number: 2210968-2019-84850
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 08/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention