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 Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Device not returned.Additional information: surgeon¿s comment about causal relationship between product and event: it is unclear if there is a direct effect.When the adhesive was used, almost all of the volume in the applicator was used.Other contributing factor: for metal allergies, prior confirmation is always performed before implantation.Other causes may be due to the patient's constitution.Additional information was requested and received.If further details are received at a later date a supplemental medwatch will be sent.What is the procedure date? no further information is available.What date did the inflammation occur on? no further information is available.Do you have any pictures of the reaction? no pictures are available.Was there any medical or surgical intervention performed to treat the patient (re-operation; re-closure; prescription medication)? if so, please specify.Treatment was performed such as removal of mesh patch.If medication was required, please clarify if it was prescribed by a physician.No further information is available.What is the most current patient status? the patient has been hospitalized.Can you identify the lot number of the product that was used? no further information is available.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no further information is available.No further information will be provided.Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? has the patient had prior exposure to dermabond, prineo or other skin adhesives? does the patient have allergies to medication, food, etc.? was an allergy test performed? if so, please provide results.What surgical preparation was used prior to, during, or after product use? how was the product applied? please describe any medical and/or surgical intervention required to treat the reaction including start date and results.Patient demographics: id, age or date of birth; bmi.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 arthroplasty on an unknown date and topical skin adhesive was used.The adhesive was used on the epidermis, skin inflammation occurred in the ward.Treatment was performed, including removal of mesh patch.The patient has been hospitalized.Treatment for epidermal inflammation is ongoing.Further details are not provided.No sample will be returned.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and received.If further details are received at a later date a supplemental medwatch will be sent.What medical and/or surgical intervention, treatment was performed to address the reaction while hospitalized? treatment was performed such as removal of mesh patch.How long was the patient hospitalized for the reaction? no further information is available.Please describe how was the adhesive was applied? when the dermabond was used, almost all of the volume in the applicator was used.Has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? no further information is available.Does the patient have allergies to medication, food, etc.? no further information is available.Was an allergy test performed? if so, please provide results.For metal allergies, prior confirmation is always performed before implantation.But the result is unknown.What surgical preparation was used prior to, during, or after product use? =>no further information is available.Patient demographics: id, age or date of birth; bmi :female.No further information will be provided.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 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12467911
• MDR Text Key: 271281822
• Report Number: 2210968-2021-08400
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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: 10/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention