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

Catalog Number CLR222

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 11/23/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Sent to the fda. Attempts to obtain the following information have been made, no response has been received to date. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. What type of topical steroids were administered? what if any other specific type of medical / surgical treatment was provided to treat the reaction? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? 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? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi, weight? patient pre-existing medical conditions (ie. Allergies, history of reactions) it was noted prineo was used for prior total knee. Was reaction reported?.

Event Description

It was reported a patient underwent a total knee replacement on an (b)(6) 2019 and topical skin adhesive was used. The adhesive was applied into the entire incision length. Patient developed an allergic reaction to adhesive on (b)(6) 2019. The entire mesh area and mesh edges was red and was very itchy. Doctor removed the mesh using saline, applied topical steroids and prescribed oral medication for patient on (b)(6) 2019. Redness subsided slightly by (b)(6) 2019, patient was discharged. Additional information was 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: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9481875
• MDR Text Key: 188031967
• Report Number: 2210968-2019-90996
• Device Sequence Number: 1
• Product Code: OMD
• 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,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 11/26/2019
• 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: 12/17/2019 Patient Sequence Number: 1