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 Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: 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? yes, prescription for allergy (antihistaminic injection), patient status/ outcome / consequences? yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? inflammation and red itchy skin, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe.Severe allergic reaction (redness and inflammation), is the patient part of a clinical study unknown, (b)(6), device property of? none, device in possession of? none.Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available of the patient reaction? yes.What was the procedure date? procedure date is (b)(6) 2022, the surgeon reported to us on (b)(6), and complaint submitted the same day.What date /day post op was the reaction noted? 1 week after the case.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? after the subcuticular closure with stratafix monocryl for the skin in a total knee replacement procedure, the prineo was applied on the incision after it was cleaned and dried, and the patient was discharged.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.Sa female, (b)(6).Patient pre-existing medical conditions (ie.Allergies, history of reactions) no history of reactions.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.Current patient status.Recovered.How many prineo products were used during the knee replacement procedure (2 ips entered)? one pc.No product is available for return.

Event Description

It was reported a patient underwent a total knee replacement on (b)(6) 2022 and topical skin adhesive was used.1 week after, when the patient came back to check the wound, the surgeon found that the wound was red and itchy.The surgeon thinks it's because of the adhesive as the skin reaction of the wound takes exactly the shape of the adhesive mesh.It was treated with prescription for allergy (antihistaminic injection).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: 13474017
• MDR Text Key: 286760106
• Report Number: 2210968-2022-00881
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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: 01/10/2022
• 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
• Treatment: STRATAFIX MONO UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female