• 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 MSH 3.8ML ADHESIVE 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 MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Model Number CLR422US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Swelling (2091); Not Applicable (3189)
Event Date 08/01/2020
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. The patient demographic info: age, gender, weight, bmi at the time of index procedure? date of the index surgical procedure? the diagnosis and indication for the index surgical procedure? on what tissue were the stratafix symmetric devices used? on what tissue were the stratfix spiral devices used? what device(s) were used on the patient¿s incision? were there any pre-existing signs/ symptoms of active infection prior to the surgical procedure? did the patient receive any prophylactic antibiotics pre, intra- or post-operation? were cultures performed? results? which tissue layer was infection observed? where and how was the prineo device used (what layer of tissue and how many layers applied)? has the patient had prior exposure to prineo or other skin adhesives? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? does the patient have allergies to medication, food, etc? was an allergy test performed? result? describe the location and appearance of the redness and inflammation. Were any photos taken ? other relevant patient history/ concomitant medications? lot number of the prineo, stratafix symmetric and stratafix spiral devices? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? note: events submitted via mw # 2210968-2020-06455, 2210968-2020-06456, 2210968-2020-06457, 2210968-2020-06458.
 
Event Description
It was reported that the patient underwent total knee replacement on an unknown date and topical skin adhesive was used. Following the procedure, the surgeon noted patient had redness, swelling and general unwell looking incision. It was reported suspected infection and patient was admitted to care facility and not seeming to respond to antibiotics. The surgeon opined issue is with incision and patient has had redness since day one. Additional information has been requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10464939
MDR Text Key204705229
Report Number2210968-2020-06454
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeCA
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 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR422US
Device Catalogue NumberCLR422US
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 Received08/28/2020
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: 08/28/2020 Patient Sequence Number: 1
-
-