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); Not Applicable (3189)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested and the following was 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.Are there any photos available? potentially.The doctor has pictures of one of the cases where a rash occurred, just unsure if it was this specific patient.Please clarify what is meant by the rash spread to the rest of the body.Unsure.The doctor just informed me that the patient also had a rash on the rest of their body similar looking to the rash around the prineo.Date of procedure? (b)(6) 2020.Date of event/rash/hospitalization? unsure.It was noted steroids were prescribed.Please provide type and dosage? unsure.Was any other medical and or surgical intervention provided to address the issue? no.Please describe how was the adhesive was applied.It was applied just as prineo is intended to be applied.I observed the staff apply prineo on other patients and they apply it correctly.What prep was used prior to, during or after prineo use? monocryl subcuticular stitch.Was a dressing placed over the incision? if so, what type of cover dressing used? unsure.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unsure.Is the patient hypersensitive to pressure sensitive adhesives? unsure.Were any patch or sensitivity tests performed? unsure.Patient demographics: initials / id, gender, age or date of birth; bmi female.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unsure.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).Unsure.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? had the same procedure done on the opposite knee 1 year prior and did not experience any sort of rash/side effect from prineo.

Event Description

It was reported a patient underwent a total knee replacement on an (b)(6) 2020 and topical skin adhesive was used.Post operatively, the patient developed a rash around the incision.The rash spread to the rest of the patients body.The patient was admitted to the hospital and was treated with steroids and other unspecified treatments.Patients current condition is unknown.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 ; 9082183429
• MDR Report Key: 10708692
• MDR Text Key: 212266046
• Report Number: 2210968-2020-08164
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• 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: Other
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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: 10/01/2020
• 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