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 Local Reaction (2035); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information: dr has been using dermabond prineo on his orthopedic cases for several years with no issues.No changes in application, skin prep, or any other potential factors.Dr.Was unable to give specific dates of surgery or lot # on the prineo 22cms that he used.Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Date of procedure? date of reaction? is a photo available of the reaction? it was noted that treatment was steroid cream and/or antibiotics.Was cream ¿prescription strength¿? please specify what medical or surgical intervention performed to treat the reaction (re-operation; re-closure; prescription steroids; prescription antibiotics; other medication prescribed)? please describe how 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, gender, age or date of birth; bmi, patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? what is the current status of the patient? product is not available for return.

Event Description

It was reported a patient underwent a total knee replacement on an unknown date in 2021 and topical skin adhesive was used.The patient presented post op with redness and irritation at closure site.The adhesive was removed and the patient was treated with a topical steroid cream and/or antibiotics.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 6/30/2021.Additional information was requested and the obtained.If further details are received at a later date a supplemental medwatch will be sent.It was noted that treatment was steroid cream and/or antibiotics.Was cream ¿prescription strength¿? -unknown.Dr.Just let me know that he used a topical steroid cream to help manage skin inflammation on dermabond prineo reaction.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? -unknown prior to procedure per dr.And staff.Is the patient hypersensitive to pressure sensitive adhesives? -unknown prior to these procedure per dr.And staff.Were any patch or sensitivity tests performed? -no.Patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? -unable to gain any specifics from dr.On patient, but during our conversation he did not indicate that the patient had previous use.1st time being exposed to a tsa product like this to his knowledge.Was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? what is the current status of the patient? -1st time prineo or any tsa was used to dr.Knowledge.Symptoms resolve within "a couple weeks" per conversation with dr.And staff.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: 11917887
• MDR Text Key: 257399282
• Report Number: 2210968-2021-05153
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• 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: 06/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention