• 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 CLR222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 07/08/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent. Date of procedure? (b)(6) 2021. On what date did the reaction occur? (b)(6) 2021. Did the patient have to be readmitted for treatment? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify. Prescribed advantan. If medication was required, was it prescribed or purchased over-the-counter. Prescribed what is the most current patient status? recovered. Can you identify the lot number of the product that was used? no. Was prineo or dermabond or any skin adhesive used on the patient in a previous surgery or wound closure? no. Who applies the product (surgeon/ assistant/ nurse)? surgeon. What prep was used prior to, during or after prineo use? betadine (povidone-iodine), or chlorhexidine? chlorhexidine. Was a protective, dry wound dressing such as gauze applied and was it applied only after the liquid topical skin adhesive has completely polymerized and the dermabond¿ prineo¿ is no longer tacky to the touch? yes. Type of dressing use on top of prineo (e. G. Honeycomb/ opsite/ gauze/ crepe): honeycomb was the application site cleansed thoroughly with saline or isopropyl alcohol to remove any remaining blood, fluids, or topical medications/anaesthetics, including skin preps, and then patted dry? yes. Was a thin layer applied as per ifu? yes. Patient hypersensitivity to cyanoacrylate, formaldehyde, or pressure sensitive adhesive and using relatable terms such as hypersensitive to bandages, tape, hobby glue, cosmetic eyelashes or artificial nails or any recent exposure? no. Were any patch or sensitivity tests performed prior to the procedure? no. Patient¿s demographics: initials, age or date of birth; bmi; gender ¿ female: (b)(6), (b)(6) yo, dob: (b)(6), bmi 23. Patient pre-existing medical conditions (e. G. Allergies, history of reactions): nka. Did the applier change a fresh pair of glove prior prineo application? yes. The images provided, are they from patients where the prineo was removed at approx. 4-5 weeks or at the 2 weeks mark? 4 weeks. Who removes the prineo? hcp or patients? patient. No product is available for return. Note: events reported on mw# 2210968-2021-08107, mw# 2210968-2021-08108, mw# 2210968-2021-08109.
 
Event Description
It was reported a patient underwent a cesarean section on (b)(6) 2021 and topical skin adhesive was used. Patient had a rash around 4-5 weeks postnatally after using the adhesive dressing. They advised to remove the dressing at 4 weeks, treated with prescribed advantan. Batch number used is unknown. Additional information has been requested.
 
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.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12436552
MDR Text Key270275078
Report Number2210968-2021-08106
Device Sequence Number1
Product Code OMD
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 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222
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 Received08/10/2021
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
-
-