• 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 MSH 3.8ML ADHESIVE 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 MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Model Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Not Applicable (3189)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Are there any photos available? potentially. The doctor has pictures of one of the cases where a rash occurred, just unsure if it was this specific patient. Please clarify what is meant by the rash spread to the rest of the body. Unsure. The doctor just informed me that the patient also had a rash on the rest of their body similar looking to the rash around the prineo. Date of procedure? (b)(6) 2020. Date of event/rash/hospitalization? unsure. It was noted steroids were prescribed. Please provide type and dosage? unsure. Was any other medical and or surgical intervention provided to address the issue? no. Please describe how was the adhesive was applied. It was applied just as prineo is intended to be applied. I observed the staff apply prineo on other patients and they apply it correctly. What prep was used prior to, during or after prineo use? monocryl subcuticular stitch. Was a dressing placed over the incision? if so, what type of cover dressing used? unsure. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unsure. Is the patient hypersensitive to pressure sensitive adhesives? unsure. Were any patch or sensitivity tests performed? unsure. Patient demographics: initials / id, gender, age or date of birth; bmi female. Patient pre-existing medical conditions (ie. Allergies, history of reactions) unsure. Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) unsure. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported by the rep post operative after a total knee procedure the patient developed a rash around the incision. The rash spread to the rest of the patients body. The patient was admitted to the hospital and was treated with steriods and other unspecified treatments. Patients current condition is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL SEALANT
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
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10708818
MDR Text Key212267136
Report Number2210968-2020-08167
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 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
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: 10/20/2020 Patient Sequence Number: 1
-
-