MAUDE Adverse Event Report: SOFREGEN MEDICAL, INC. SERI SURGICAL SCAFFOLD

Model Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Post Operative Wound Infection (2446)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

This is the initial medical device reporting form from sofregen complaint first filed on august 24, 2017.This is a resubmission of the initial reporting form requested by the fda via email on april 10, 2020.Seri surgical scaffold was used in combination with breast implants and followup procedures were required to remove the mesh and implants.

Event Description

On 07/24/2017, a patient contacted a representative of sofregen via phone and reported issues she had experienced with the seri surigical scaffold.She provided the following information via email on 07/25/2017: "this is a follow up email from our phone conversation today, on july 23rd 2017, involving my emergency surgery on (b)(6) 2017.As a result of being greatly infected from the seri silk that was covered in "biofilm".I have medical reports confirming that and i am currently recovering from surgery.On (b)(6) 2017 i had surgery in (b)(6) performed by dr.(b)(6).After having problems with capsule contracture in the past, dr.(b)(6) recommended the seri silk to be placed with my implants to reduce the risk of a capsule contracture to reoccur.In early (b)(6) 2017, less than 6 months after surgery, i noticed my left breast changing and becoming more firm.After consulting with dr.(b)(6) he confirmed i had a grade iv capsule contracture.Shortly after my appointment he prescribed singular to help reduce the capsule contracture.By the middle of (b)(6), i experienced more pain associated with my left breast, i thought it must be the singular breaking down the capsule contracture.At that time, i asked my employer if i could be moved to an office job and not be on my feet working constantly with my arms and hands, as well as working on up to 20 clients at a time.My director said they did not have any openings at that time in the administration or admissions office.I asked her to let me know if you anything opens up.Meanwhile the schedule and physical aspects of my job caused me to resign, my last day was (b)(6) 2017.Just three days later, as i was leaving for (b)(6) to visit my family and friends, my daughter (b)(6) noticed my breast was red and warm to the touch.She said "mom i think you have an infection".Upon my arrival to (b)(6) i contacted dr.(b)(6), he advised me to seek medical attention from a plastic surgeon in (b)(6) and try to get on an antibiotic.I looked on my humana health insurance and found dr.(b)(6).I was able to get in with him on (b)(6) 2017 and he put me on the anabiotic cephalexin.On (b)(6) 2017, exactly one week later, the pain was unbearable and the infection started draining, i became very scared and drove myself to the emergency room at (b)(6) medical center in (b)(6).Once i got there, the medical staff was great and informative.I became more aware how dangerous the infection could have gotten if it became toxic and gotten into my bloodstream.After taking blood for growing cultures, they put me on an intravenous anabiotic and fluids.Then they admitted me and got in touch with dr.(b)(6).Dr.(b)(6) contacted me as soon as i was admitted and informed me that the implant and infection needed come out right away.I was quickly prepped for surgery.My insurance would only pay for the infected implant to come out.I was kept overnight at the hospital and released on (b)(6) 2017.Then a drain tube was placed and it had been draining for almost two weeks when removed on (b)(6) 2017.I was supposed to fly home on (b)(6) 2017, however i had to postpone my flight until (b)(6) 2017.I was placed on 750 mg of levofloxacin/ levaquin for 2 weeks.It makes me dizzy and sick to my stomach.I am currently trying to get short-term disability, until i can feel better and can get back to work.My left breast looks very deformed and i am devastated, find myself crying and depressed.This has been life changing in the worst way.Having had this result of using seri silk, i would have never made that choice and put my life at risk by having it placed in my body.I hope you make your consumers aware that they could risk their lives by using your product.Please contact me as soon as possible, as i would like to file a formal complaint." on 07/26/2017, she provided the following information: "thank you for contacting me regarding my complaint.I have my medical and pathological reports to provide along with pictures of the progression of the infection in my left breast as it occurred.Please have your team get in touch with me and i will be happy to provide the documentation and my doctor's information, as well.This has been very devastating and i am still healing from having the infection, capsule, implant and seri silk removed.Not only has the surgery left me looking deformed, i'm also very weak and unable to work at this time.I appreciate your email and concern to get me into contact with the right person to get my complaint filed.".

• Brand Name: SERI SURGICAL SCAFFOLD
• Type of Device: SERI SURGICAL SCAFFOLD
• Manufacturer (Section D): SOFREGEN MEDICAL, INC.; 200 boston ave; suite 1100; medford, ma
• Manufacturer Contact: 200 boston ave; suite 1100; medford, ma ; 6518873
• MDR Report Key: 7040631
• MDR Text Key: 240471123
• Report Number: 3013417188-2017-00013
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BREAST IMPLANTS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female