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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/07/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a right total knee replacement on an unknown date in (b)(6) 2022 and topical skin adhesive was used.Patient experienced an allergic reaction upon 2nd exposure to adhesive.Allergy was discovered pod 14.Adhesive was removed and patient was treated with topical corticosteroid 0.05%.Was prescribed, additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: customer reference/po/service? (b)(6) hospital, did the patient experience a post-op device malfunction? no, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? topical corticosteroids 0.05% was prescribed, patient status/ outcome / consequences? yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? allergic reaction upon 2nd exposure to dermabond prineo post-tkr pod 14 was observed.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe.Topical corticosteroids 0.05% was prescribed, is the patient part of a clinical study? unknown.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.What was the procedure date? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? current patient status.No product is available for return.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 14437208
• MDR Text Key: 292071722
• Report Number: 2210968-2022-03875
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/19/2022
• 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