• 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 42CM CUTANEOUS TISSUE ADHESIVE WITH MESH

  • 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 42CM CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Catalog Number CLR422
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)
Event Date 07/28/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The following information was requested however, not received to date: please provide photos. Specific procedure name. Please indicate any medical or surgical interventions performed. Please describe how was the adhesive was applied on the tape. 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? what is the physicians opinion of the contributing factors to the infection? 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). Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? were any cultures performed? results? 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 sclerosis procedure on (b)(6) 2019 and topical skin adhesive was used. The patient returned after 2 weeks post operatively, with infected spots in the wound due to wound opening. Additional information has been requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDERMABOND PRINEO 42CM
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
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 Key8917045
MDR Text Key155103014
Report Number2210968-2019-85951
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K163645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberCLR422
Device Lot NumberMGJ850
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 Received08/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2018
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: 08/21/2019 Patient Sequence Number: 1
-
-