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

Catalog Number CLR602

Device Problem Contamination (1120)

Patient Problems Skin Irritation (2076); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.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.How was the prineo applied on the mesh? what prep was used prior to product application? what type of cover dressing used?.Can you identify the lot number of the product that was used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that a patient underwent a total left knee replacement procedure on (b)(6) 2018 and topical skin adhesive was used over the incision.The patient experienced an adverse event following the surgery.The patient was readmitted to the hospital on (b)(6) 2018 with a crp of 69 and esr of 77.The initial assumption was that he had a severe wound infection.The wound however was healing well and no organisms were grown from the swab.The patient was admitted for a week and given antibiotics and reviewed by the microbiologist who thought it was a reaction to the dressing.The surgeon has been using the topical skin adhesive for three years with no previous issues.The dermatologist report indicates that there may be environmental factors involved such as dry conditions.Additional information has been requested.

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to fda: (b)(4) 2018.Additional information was requested and the following was obtained: - how were the reactions treated/resolved? information has not been provided - lot/batch? - we have not been able to confirm ¿ how was the prineo applied on the mesh? as per ifu ¿ what prep was used prior to product application? incision and surrounding area wiped with chlorhexidine and then dried with a second pack ¿ what type of cover dressing used? dry gauze is placed over the dried prineo.Webril is the next layer, followed by crepe bandage and coban wrap.¿ is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? currently being assessed by dermatologist ¿ patient pre-existing medical conditions - nothing additional to original report.

• 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; 982 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: 7931335
• MDR Text Key: 122624271
• Report Number: 2210968-2018-76282
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

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: CLR602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 10/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention