• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. DERMABOND PRINEO 22CM SURGICAL SEALANT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDERMABOND PRINEO 22CM
Type of DeviceSURGICAL 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 Key8045128
MDR Text Key126351524
Report Number2210968-2018-77008
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
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 Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
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
-
-