MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 04/21/2021

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? on (b)(6) 2021.On what date did the reaction occur? on (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.Topical steroid, over the counter.If medication was required, was it prescribed or purchased over-the-counter.Fucidin through gp prescription.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), bmi 20.5.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#: 2210968-2021-08106, 2210968-2021-08108, and 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 fucidin and topical steroid over the counter.Batch number used is unknown.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL 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 Key: 12436554
• MDR Text Key: 270326253
• Report Number: 2210968-2021-08107
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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 Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR