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 Inflammation (1932); Skin Irritation (2076); Not Applicable (3189)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). The following information was requested, however not received. To date the device has not been returned. If further details are received at a later date a supplemental medwatch will be sent. Date of tkr? confirm (b)(6) 2020 was the date of reaction? it was noted that surgical intervention was provided to remove the prineo. Please detail what was done and any treatment provided (reoperation; reclosure; prescriptions; antibiotics prescribed) to address reaction? please indicate any medical or surgical interventions performed. Please describe how was 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; age or date of birth; bmi ; patient pre-existing medical conditions (ie. Allergies, history of reactions) does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails). Current patient condition? has this patient been exposed to prineo/dermabond in a previous procedure? 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 replacement on and unknown date and surgical sealant was used. Post operatively, the patient came back with an inflamed wound. Patient wasn't known to have any allergies. They are taking the patient to the or to remove the adhesive. No device will be returned. 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
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10263868
• MDR Text Key: 198513934
• Report Number: 2210968-2020-05239
• Device Sequence Number: 1
• Product Code: OMD
• 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

• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2020
• 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: 07/13/2020 Patient Sequence Number: 1