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 Rash (2033); Skin Discoloration (2074)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested however not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Please provide photos of the reaction.What medical and or surgical intervention was provided to address the issue while hospitalized or post operatively? please describe how was the adhesive was applied.What prep was used prior to, during or after prineo 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? were any patch or sensitivity tests performed? patient demographics: initials / id, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions) does the patient use or 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? can you identify the lot number of the product that was used? current patient status.

Event Description

It was reported a patient underwent a c-section on (b)(6) 2020 and topical skin adhesive with mesh was used.Twenty four hours post op, the patient had a rash at the exact outline mesh.It was removed and the patient kept an extra night for observation and prescribed clobetasol/steroid.She was discharged the next day and is fine.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/24/2020.Additional information: h6 - health effect - clinical code e1716.Corrected data: h6: health effect - impact code f08.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 corrected data: h6: health effect - impact code f08.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10809506
• MDR Text Key: 215299690
• Report Number: 2210968-2020-08849
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: 11/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention