• 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. PRINEO SKIN CLOSURE SYSTEM 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. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Reaction (2414)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the device or further details are received at a later date, a supplemental medwatch will be sent. 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. Please describe any medical or surgical intervention provided to treat the blistering or the wound dehiscence? what was the angle of the knee during application? do you have any pictures of the reaction? size of dehiscence at central portion of incision? procedure date, location and incision size of product application? what prep was used prior to prineo use? please describe how the adhesive was applied on the tape? was the dermabond liquid adhesive placed to cover the entire length of the mesh? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was a dressing placed over the incision? if so, what type of cover dressing used? date of reaction. How large of an area does the reaction cover? did the skin reaction extend beyond the borders of the tape. Was the product removed? was another method used to close the incision? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? lot number involved. What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions). For female patients ask if they were exposed to similar products, such as artificial nails. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported that the patient underwent total knee arthroplasty procedure on an unknown date and topical skin adhesive was used. The patient returned to the office two weeks post-op with a blister and some wound dehiscence at the central portion of the incision that was closed with topical skin adhesive. Additional information has been requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRINEO SKIN CLOSURE SYSTEM
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 PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6198031
MDR Text Key63074230
Report Number2210968-2016-15622
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 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
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 Treatment Data
Date Received: 12/22/2016 Patient Sequence Number: 1
-
-