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

Model Number CLR222US

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

Patient Problems Rash (2033); Local Reaction (2035)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and was obtained.If further details are received at a later date a supplemental medwatch will be sent.What prep was used prior to, during or after prineo use? unsure.Was a dressing placed over the incision? if so, what type of cover dressing used? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.Patient demographics: initials / id, gender, age or date of birth; bmi female, unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) no.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? yes, this was the second time that they used prineo on this patient.First time was 1 year previous to this procedure.What is the current status of the patient? she took out antibiotics and the rash has resolved.No product to be returned.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 mastectomy revision on (b)(6) 2021 and topical skin adhesive was used.On (b)(6) 2021 the patient had an outbreak of rashes.Treated with benadryl (25 mg tablets) and cortisone cream.On (b)(6) 2021 steroid 6 day pack started.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: 11798477
• MDR Text Key: 249739059
• Report Number: 2210968-2021-04384
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• 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