• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Irritation (2076)
Event Date 02/08/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? 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: was the patient 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? what is the most current patient status? 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.
 
Event Description
It was reported a patient underwent a single stage breast reconstruction on (b)(6) 2019 and skin adhesive was used. Two days post op, patient complained of feeling irritability and 3 days post op an "angry" red rash appeared under the adhesive on the wound. Surgeon removed using petroleum based product as concerned about reaction and infection given implantable device with breast implant. Surgeon has used some steroids on the area. Patient currently being monitored as outpatient - rash has settled but still active.
 
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 PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8431900
MDR Text Key139180175
Report Number2210968-2019-79541
Device Sequence Number1
Product Code OMD
UDI-Device Identifier10705031237339
UDI-Public10705031237339
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K133864
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 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
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 Received02/21/2019
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: 03/19/2019 Patient Sequence Number: 1
-
-