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

Catalog Number CLR222

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

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: it was reported that this event has occurred on multiple occasions. What is the total number of procedures? for each patient event, please provide the following information: have any of these events been previously reported to ethicon? if so, provide the respective reference number(s). No, none reported previously. Does the medical professional believe that the oozing is related to the stratafix, vicryl suture, or prineo? the surgeon believes that the oozing is cause by closure technique, but is unsure on how to fix it and looking to me for guidance. What is the procedure name and initial procedure date? tka, and roughly 3 weeks ago. How was the prineo applied on the mesh? knee is bent at near 90 degrees, incision and surrounding skin is dried, mesh is applied, liquid adhesive is then applied and allowed to dry for about 60 seconds. I do not have an exact date, but it was within a few days of application. What date did the prineo come off pre-maturely occur on? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Prineo was removed and patient had to have wound cleaned and reclosed. Can you identify the product code and lot number of the product that was used? no, i do not have the code or lot number. Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions). I was told that one of the patients was larger, but am unsure of preexisting conditions for the other patient.

Event Description

It was reported that a patient underwent a total knee arthroplasty procedure on an unknown date and topical skin adhesive was used. The technique is barbed suture for the fascia and many tight interrupted vicryls on the subcutaneous. The surgeon cleans the skin surface and dries it, then applies the topical skin adhesive. Approximately seventy five percent of the way down on the incision, there is a small oozing type bleed through on the topical skin adhesive. The pa attempts to apply pressure to the bleeding spot to get it to stop and has applied skin glue (exofin) on top of the topical skin adhesive. Topical skin adhesive was removed and the patient had to have wound cleaned and reclosed. Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM
• 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: 8045128
• MDR Text Key: 126351524
• Report Number: 2210968-2018-77008
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/10/2018
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/07/2018 Patient Sequence Number: 1