• 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 CLR602
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. 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. Do you have any pictures of the reaction? what is meant by the product remained in patient for 30 days? please explain the location and incision size of product application? what is meant that ¿patient has many excoriations through skin¿? initial procedure date. Date that reaction first began. What prep was used prior to prineo use? was the prep allowed to dry prior to prineo mesh application? please describe how the adhesive was applied on the tape? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and allowed to dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? what does the reaction look like? please provide details. How large of an area does the reaction cover? did the skin reaction extend beyond the borders of the tape. What was done to address the reaction? what type of medication? dose? when (date) administered?.
 
Event Description
It was reported that a patient underwent a mammoplasty procedure on an unknown date and topical skin adhesive was used. Post op day 30, the patient presented with a local allergic reaction in the area of contact with the product. On the 31st day the surgeon removed the product. The allergy continues to increase and the patient has many excoriations through the skin. Drug intervention was necessary. 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
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6628943
MDR Text Key77176373
Report Number2210968-2017-32472
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/24/2017
Device Catalogue NumberCLR602
Device Lot NumberKGH404
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 Received05/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2015
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: 06/08/2017 Patient Sequence Number: 1
-
-