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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 06/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Hematoma; blistering; topical skin adhesive removal; drainage.Blistering occurred; hematoma occurred.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 procedure name? tkr.What is the procedure date? (b)(6) 2017.How was the device was used (what layer of tissue and how many layers applied)? skin layer.One layer.What was the location and incision size of prineo application? knee, about 15cm.What prep was used prior to prineo application? sterile saline water.Was the prep allowed to dry prior to prineo mesh application? yes.Please describe how the adhesive was applied on the tape? applied onto the mesh.Was the mesh placed over the entire length of the incision? yes.Was the dermabond liquid adhesive placed to cover the entire length of the mesh? yes and slightly beyond the margin of the mesh.Did the prineo mesh extend beyond the patient incision? yes.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? no.Was the skin prep solution wiped off and let dry before applying adhesive? not applicable.Was a dressing placed over the incision? if so, what type of cover dressing used? yes.How large of an area does the reaction cover? see pic.Do you have any pictures ? yes.What was done to address the reaction? were steroids or antibiotics prescribed? remove prineo.Was there any medical or surgical intervention to treat the reaction? if so, please clarify - no.Was the blister drained or aspirated? yes.Was the product removed? yes was another method used to close the incision? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.What is the most current patient status? recovered.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) - chinese, male, above 70 year old.Has prineo event been used on the patient in a previous surgery? no.

Event Description

It was reported that a patient underwent a total knee replacement procedure on (b)(6) 2017 and topical skin adhesive was used.On (b)(6) 2017, the patient developed blistering beneath the skin and hematoma.The surgeon removed the topical skin adhesive and allowed the blood to drain.A dressing was placed.There were no adverse consequences for the patient.Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• 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 PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6678866
• MDR Text Key: 78764942
• Report Number: 2210968-2017-32814
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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