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); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4). Additional information received: 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? patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? patient experienced allergic contact dermatitis after second exposure to dermabond prineo. Symptoms include redness and itchiness. Right total knee replacement was done on (b)(6) 2022 and the contact dermatitis was discovered pod 10. , was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe yes, topical steroid cream was given to patient to treat the contact dermatitis, is the patient part of a clinical study no, device property of none, device in possession of none additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Was steroid cream prescription strength? 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)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? 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.

Event Description

It was reported a patient underwent a total knee replacement on (b)(6) 2022 and topical skin adhesive was used. Post op on (b)(6) 2022, the patient had experience allergic contact dermatitis on right knee after use of adhesive. Allergic reaction was discovered post-op day 11. Symptoms include redness and itchiness. Topical steroid cream was given to patient to treat the contact dermatitis, 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: 14014051
• MDR Text Key: 288784363
• Report Number: 2210968-2022-02375
• Device Sequence Number: 1
• Product Code: OMD
• 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

• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/05/2022 Patient Sequence Number: 1