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

Catalog Number CLR602

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint: (b)(4).Additional information: h6 component code: g07002.Additional information provided: 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? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown, additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction? infection description of event, symptoms, manifestation of reaction infection what was the procedure date? was any prescription strength medication prescribed? please specify? was the topical steroid prescription strength? were any other prescription medications prescribed? was any surgical intervention performed? were any cultures taken? results? 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? product code and/or lot of product used? current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis.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.

Event Description

It was reported a patient underwent an abdominoplasty on an unknown date and topical skin adhesive was used.After two weeks, an intradermal point of the incision becomes infected.It was used correctly, except that a cut was made to the product in the drainage area, so the infection could have entered there.Additional information has been requested.

Manufacturer Narrative

Product complaint#: (b)(4).Additional information: a2.Patient age at the time of event, 2.Age unit, a3, h6.Health effect - clinical code, h6.Health effect - impact code.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction? infection no.Description of event, symptoms, manifestation of reaction infection.Inflammation and infection of two points.What was the procedure date? on (b)(6) 2023.Was any prescription strength medication prescribed? please specify? amoxicilina con clavulanico por 10 dias.Was the topical steroid prescription strength? no.Were any other prescription medications prescribed? derivative healings and at the end of the antibiotic, sutured the skin.Was any surgical intervention performed? abdominoplastia.Were any cultures taken? results? no.Please describe how was the adhesive was applied.Previus intradermica, then the mesh an then dermabond.We cover all the mesh with prineo.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? drenaje.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? i don't know, first time using the product in the patient.Is the patient hypersensitive to pressure sensitive adhesives? no.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no.Patient demographics: initials / id, gender, age or date of birth; bmi.Women, 54 years, healthy.Patient pre-existing medical conditions (ie.Allergies, history of reactions).No.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? i don't know.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.Product code and/or lot of product used? don't have them.Current patient status.Ok.Name of surgeon? dr.(b)(6).What is the physician¿s opinion as to the etiology of or contributing factors to this event? multifactorial, bad luck.Is product available to return for analysis.No.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 PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17931345
• MDR Text Key: 325618142
• Report Number: 2210968-2023-07742
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female