MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information was requested and obtained: what is the procedure date? not known.What date did the reaction occur on? not known.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Dermatologist appointments and steroid prescription on patient.What is the most current patient status? recovered can you identify the product code and lot number of the product that was used? clr222us, lot#s not known.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? not known.The following information was requested however, not received.If the further details are received at a later date a supplemental medwatch will be sent.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 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? informed the product will not be returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 knee procedure on an unknown date in 2020 and topical skin adhesive with mesh was used.Patient had reaction to adhesive two weeks post op with a rash that spread to his entire body, other knee and face.Referred to dermatologist.Diagnosed as dermatitis and prescribed steroid for 1 month and painful.Patient has since recovered.Lot number not known additional information has been requested.

• 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
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11365440
• MDR Text Key: 233242886
• Report Number: 2210968-2021-01691
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• 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