MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR602US

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

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: did the patient experience a post-op device malfunction? unknown, 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? unknown, patient status/ outcome / consequences, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, device property of: none, device in possession of: none.Additional information has been requested and received.Date of procedure? (b)(6) 2022 patient: age? sex? (b)(6) female.Procedure? bilateral breast reduction.Which prineo product? 60cm.Scrub nurse name? se scrub ew assistant.Time length until reaction occurred/reported? 2 days.What is the current patient status, was any intervention or treatment needed for recovery? resolving: steroids and ab¿s.What did the patient experience report/ reaction? redness and blistering was there any changes to the surgeons routine/application or use of the prineo? no.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available of the patient reaction? 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, 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 available for return.

Event Description

It was reported a patient underwent a bilateral breast reduction on (b)(6) 2022 and topical skin adhesive was used.Patient had skin reaction.2 days post op, patient had redness and blistering.Resolving with treatment of steroids and antibiotics.Additional information has been requested.

Manufacturer Narrative

Product complaint#: (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available of the patient reaction? no.Please describe how was the adhesive was applied.It was applied as per instructions for use.High volume user of the product and familiar with application.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? yes.If so, what type of cover dressing used? com-feel.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? none known.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? yes.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no, as per initial screening questions.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.No product is available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 60CM 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13996839
• MDR Text Key: 292482573
• Report Number: 2210968-2022-02356
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• UDI-Public: 10705031024168
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K152490
• 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,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR602US
• Device Catalogue Number: CLR602US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2022
• 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
• Patient Age: 24 YR
• Patient Sex: Female