MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: revision: hospital/date: (b)(6), (b)(6) 2018 (current inpatient).Primary diagnosis: wound breakdown/infection.Procedure 2: debride & re-suture lumbar wounds x2.Wound closure:1 vicryl/1 vicryl/2.0 vicryl/3.0 nylon/ tension sutures.Antimicrobial therapy: iv tazocin 4.5g three time a day.What was the date of the second procedure? on (b)(6) 2018.Were any cultures taken of the wound? what were the results of the cultures? on (b)(6) 2018: microbiology from wound swab indicates light growth of escherichia coli & mixed anaerobes & staph aureus & granulicatella adiacens.What is the surgeon opinion as to relationship of the stratafix symmetric suture and the patient infection? dr (b)(6) advised that there were a few factors that "has" contributed: prineo being removed too early by staff or moisture and rolled off (re-trained); insufficient closure leaving dead space (re-trained assistant).Since addressing these issues, surgeon's patients all healing well.Can you provide patient age, gender, weight, other medical conditions? co-morbidities: type 2 diabetes, hypertension, hx cancer.What is the current condition of the patient? follow-up appointments: tba: practice nurse.On (b)(6) 2019: surgeon.

Event Description

It was reported that patient underwent left l4/5 decompression and l3-l5 fixation with fusion on (b)(6) 2018 and topical skin adhesive was used.The topical skin adhesive was used for wound closure.The patient experienced wound dehiscence and infection on (b)(6) 2018.A revision procedure was performed on (b)(6) 2018 for debridement.The surgeon opined that the possible outcome was possible due to topical skin adhesive being removed too early by staff or moisture and rolled off and/or insufficient closure leaving dead space.The patient was treated with iv antibiotics and current condition is unknown.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Procedure 1: transfer from (b)(6) hospital.Hospital/date: (b)(6) 2018.Primary diagnosis: l4 # l3/4/5 stenosis.Procedure 1: left l3/4/5 decompression; l2-l5 fixation; l3-l5 posterolateral fusion.Implants: everest screws (lhc), cement.Wound closure: 1 stratafix/2.0 stratfix/prineo; 5.0 prolene for dural hole.Patient notes: (b)(6) 2018: routine post-op ct.Procedure 2: hospital/date: (b)(6) 2018 (current inpatient).Primary diagnosis: wound breakdown/infection.Procedure 2: debride & re-suture lumbar wounds x2.Wound closure:1 vicryl/1 vicryl/2.0 vicryl/3.0 nylon/ tension sutures.Antimicrobial therapy: iv tazocin 4.5g tds.Patient notes: (b)(6) 2018: microbiology from wound swab indicates light growth of escherichia coli & mixed anaerobes & staph aureus & granulicatella adiacens.Follow-up appointments: tba: practice nurse (b)(6) 2019: (b)(6).Co-morbidities type 2 diabetes, hypertension, hx cancer.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8263295
• MDR Text Key: 133701874
• Report Number: 2210968-2019-78494
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• 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: 01/02/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/20/2019
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 02/18/2019
• Patient Sequence Number: 1
• Treatment: PROLENE SUTURE , SCREWS, STRATAFIX SUTURE
• Patient Outcome(s): Required Intervention