MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: what is the initial procedure date? 04/09/2018 how was the prineo adhesive applied on the mesh? yes what date did the reaction occur on? patient re-admitted on 05/11/2018 for hip abscess.Per nursing staff, at that time prineo was still in place and was ¿dirty¿.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Pt was taken back to or on several occasions for i&ds and cultures.Patient has been on iv abx and has had 2 re-admissions since the original surgery.Can you identify the lot number of the product that was used? dermabond prineo 22cm clr222us.What is the most current patient status? currently, patient is admitted and receiving iv abx and has a wound vac.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) 74 yo m; bmi=29.21; past medical hx: arthritis, diabetes, hyperlipidemia, hypertension; allergies to adhesive tape & latex per chart.

Event Description

It was reported that a patient underwent a total hip arthroplasty on 4/09/2018 and topical skin adhesive was used to close the incisions.The patient returned to the hospital with very dirty topical skin adhesive on the skin, showing a surgical site infection.The patient was readmitted on (b)(6) 2018 for hip abscess.The patient was taken back to the or on several occasions for i&d's and cultures.Patient has been on iv antibiotics and has had two re-admissions since the original surgery.Currently, the patient is admitted and receiving iv antibiotics and has a wound vac.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7605205
• MDR Text Key: 111172964
• Report Number: 2210968-2018-73496
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• 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: 05/18/2018

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: No Information
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/15/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR