MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number CLR422

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

Patient Problems Itching Sensation (1943); Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.Name of procedure performed? unknown.Date of procedure? unknown.Date of reaction? unknown.Is a photo available of the reaction? no.Were there any medical or surgical interventions performed? no.Please describe how the adhesive was applied.What prep was used prior to, during or after prineo use? chloraprep stick before surgery, then skin washed down and dried before applying prineo.Was a dressing placed over the incision? if so, what type of cover dressing used? yes, op-site for 2 weeks.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? no just asked if they were allergic to anything.Patient demographics: initials / id, gender, age or date of birth; bmi: female.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no.Was prineo skin adhesive used on the patient in a previous surgery or wound closure? no.What is the current status of the patient? recovered and fine.Was the steroid cream prescription strength? yes.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent a paediatric spinal deformity procedure on an unknown date and topical skin adhesive was used.There is redness and itching where the dressing was applied.Treated with prescription steroid cream and further medication.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• 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: 11771472
• MDR Text Key: 264273018
• Report Number: 2210968-2021-04227
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163645
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CLR422
• Device Lot Number: QJBDBL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention