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 Inflammation (1932); Itching Sensation (1943); Blister (4537); Swelling/ Edema (4577)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Device not returned. Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent. What is the procedure date? tkr. What date did the reaction occur on? approx. 1 week post-op. What does the reaction look like and how large of an area does the reaction cover? n/k. Do you have any pictures of the reaction? no. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Prescriptiontopical steroid used. What is the most current patient status? n/k. Can you identify the lot number of the product that was used? not provided was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? n/k. Please describe how the adhesive was applied. Unknown. What prep was used prior to, during or after prineo use? betadine. Was a dressing placed over the incision? if so, what type of cover dressing used? unknown. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? no. Patient demographics: initials / id, gender, age or date of birth; bmi: unknown. Patient pre-existing medical conditions (ie. Allergies, history of reactions): unknown. Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown. Surgeon has been using product for a long time. No product will be returned.

Event Description

It was reported a patient underwent a total knee replacement on an unknown date in december 2020 and topical skin adhesive was used. About 1 week post operatively, patient had inflammation, blistering, itchiness, and swelling where the adhesive was placed. Prescription topical steroid administered. 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: 11593134
• MDR Text Key: 243918180
• Report Number: 2210968-2021-02906
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/30/2021 Patient Sequence Number: 1